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A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01237587
Recruitment Status : Completed
First Posted : November 9, 2010
Results First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Drug: Duloxetine
Drug: Placebo
Enrollment 184
Recruitment Details 13 week Double-Blind Treatment Phase (Acute Phase), followed by 26 week Open-Label Extension Treatment Phase (Extension Phase), followed by 1 week Taper/Discontinuation Phase.
Pre-assignment Details  
Arm/Group Title Duloxetine/Duloxetine Placebo/Duloxetine
Hide Arm/Group Description

Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).

Participants who received higher doses of Duloxetine in acute & extension phase received gradually lower doses of duloxetine & participants on lower doses of Duloxetine in acute phase received placebo during 1-week tapering phase.

Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).

Participants who received placebo in acute phase received placebo & participants who received higher doses of Duloxetine in extension phase received gradually lower doses of duloxetine during1-week tapering phase.

Period Title: Double Blind Treatment (Acute Phase)
Started 91 93
Received at Least One Dose of Study Drug 91 93
Completed 74 75
Not Completed 17 18
Reason Not Completed
Adverse Event             5             1
Lack of Efficacy             1             3
Lost to Follow-up             2             3
Parent/Caregiver Decision             2             4
Protocol Violation             4             3
Withdrawal by Subject             3             4
Period Title: Open Label Treatment (Extension Phase)
Started 74 75
Received at Least One Dose of Study Drug 74 75
Completed 56 50
Not Completed 18 25
Reason Not Completed
Lost to Follow-up             4             3
Adverse Event             5             5
Lack of Efficacy             2             4
Parent/Guardian Decision             2             4
Withdrawal by Subject             0             5
Sponsor Decision             1             0
Physician Decision             4             4
Period Title: Taper Phase
Started 36 [1] 44 [1]
Completed 31 34
Not Completed 5 10
Reason Not Completed
Adverse Event             0             2
Protocol Violation             2             0
Lack of Efficacy             2             5
Parent/Guardian Decision             0             2
Sponsor Decision             1             0
Withdrawal by Subject             0             1
[1]
Participants who discontinued Acute or Extension phase had an option to enter tapering phase.
Arm/Group Title Duloxetine Placebo Total
Hide Arm/Group Description

Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).

Participants who received higher doses of Duloxetine in acute & extension phase received gradually lower doses of duloxetine & participants on lower doses of Duloxetine in acute phase received placebo during 1-week tapering phase.

Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).

Participants who received placebo in acute phase received placebo & participants who received higher doses of Duloxetine in extension phase received gradually lower doses of duloxetine during 1-week tapering phase.

Total of all reporting groups
Overall Number of Baseline Participants 91 93 184
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 93 participants 184 participants
15.74  (1.379) 15.33  (1.421) 15.53  (1.411)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 93 participants 184 participants
Female 73 65 138
Male 18 28 46
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 93 participants 184 participants
Hispanic or Latino 36 39 75
Not Hispanic or Latino 54 54 108
Unknown or Not Reported 1 0 1
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 93 participants 184 participants
American Indian or Alaska Native 1 0 1
Asian 6 7 13
Native Hawaiian or Other Pacific Islander 0 1 1
Black or African American 7 8 15
White 72 70 142
More than one race 4 6 10
Unknown or Not Reported 1 1 2
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Puerto Rico Number Analyzed 91 participants 93 participants 184 participants
2 3 5
Argentina Number Analyzed 91 participants 93 participants 184 participants
19 19 38
United States Number Analyzed 91 participants 93 participants 184 participants
64 64 128
India Number Analyzed 91 participants 93 participants 184 participants
6 7 13
Brief Pain Inventory (BPI) Modified short form (SF) Adolescent version (AV)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Average Pain Number Analyzed 90 participants 91 participants 181 participants
5.7  (1.37) 5.6  (1.55) 5.65  (1.46)
Worst Pain Number Analyzed 91 participants 93 participants 184 participants
7.1  (1.8) 6.9  (1.9) 7.0  (1.9)
Least Pain Number Analyzed 91 participants 93 participants 184 participants
3.7  (2.1) 3.8  (2.0) 3.8  (2.1)
Pain Right Now Number Analyzed 91 participants 93 participants 184 participants
5.2  (2.4) 5.2  (2.3) 5.2  (2.4)
General Activity Number Analyzed 91 participants 93 participants 184 participants
5.2  (2.0) 5.1  (2.0) 5.2  (2.3)
Mood Number Analyzed 91 participants 93 participants 184 participants
4.9  (2.6) 5.0  (2.6) 5.0  (2.6)
Walking Ability Number Analyzed 91 participants 93 participants 184 participants
4.1  (2.8) 4.5  (2.8) 4.3  (2.8)
Normal Work Number Analyzed 91 participants 93 participants 184 participants
4.6  (2.6) 4.9  (2.5) 4.8  (2.6)
Relations with other people Number Analyzed 91 participants 93 participants 184 participants
3.7  (2.7) 3.7  (2.8) 3.7  (2.8)
Sleep Number Analyzed 91 participants 93 participants 184 participants
5.9  (2.8) 5.5  (3.0) 5.7  (2.9)
Enjoyment of Life Number Analyzed 91 participants 93 participants 184 participants
4.1  (3.1) 4.3  (2.8) 4.2  (3.0)
School Work Number Analyzed 91 participants 93 participants 184 participants
4.8  (3.0) 4.3  (3.2) 4.6  (3.1)
[1]
Measure Description: BPI Modified SF AV is a scale that measures severity & interference of pain. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). 4 questions assessing severity for worst pain, least pain, average pain in past 24 hours, & pain right now.Interference scores range from 0 (does not interfere) to 10 (completely interferes).7 questions assessing interference of pain in past 24 hours on general activity, mood, walking ability, normal work, relations with other people, sleep, & enjoyment of life. Adolescent Version has 8th question for interference of pain on school work.
[2]
Measure Analysis Population Description: All randomized participants who had baseline BPI score.
Pediatric Pain Questionnaire (PPQ)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mm
Average Pain Number Analyzed 87 participants 86 participants 173 participants
61.8  (19.5) 58.1  (22.3) 58.94  (20.9)
Worst Pain Number Analyzed 87 participants 86 participants 173 participants
77.4  (20.3) 75.5  (20.4) 76.5  (20.4)
pain now Number Analyzed 87 participants 86 participants 173 participants
50.1  (27.5) 52.0  (25.2) 51.0  (26.4)
[1]
Measure Description: Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 millimeter (mm) VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).
[2]
Measure Analysis Population Description: All randomized participants who had baseline PPQ score.
Clinical Global Impression (CGI) Severity: Mental Illness   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 90 participants 92 participants 182 participants
2.1  (1.2) 2.0  (1.1) 2.05  (1.15)
[1]
Measure Description: Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).
[2]
Measure Analysis Population Description: All randomized participants who had baseline CGI mental illness score.
Clinical Global Impression (CGI) Severity: Overall Illness   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 90 participants 92 participants 182 participants
4.1  (0.9) 4.1  (0.8) 4.1  (0.9)
[1]
Measure Description: Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of Juvenile Primary Fibromyalgia Syndrome (JPFS), including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.
[2]
Measure Analysis Population Description: All randomized participants who had baseline CGI overall illness score.
Functional Disability Inventory (FDI) Child score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 87 participants 88 participants 175 participants
23.3  (11.1) 22.3  (9.9) 22.8  (10.5)
[1]
Measure Description: Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.
[2]
Measure Analysis Population Description: All randomized participants who had baseline FDI child score.
Functional Disability Inventory (FDI) Parent Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 86 participants 87 participants 173 participants
22.4  (11.4) 22.3  (10.7) 22.4  (11.1)
[1]
Measure Description: Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.
[2]
Measure Analysis Population Description: All randomized participants who had baseline FDI parent score.
Children's Depression Inventory (CDI)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 89 participants 89 participants 178 participants
13.5  (7.1) 13.1  (7.7) 13.3  (7.4)
[1]
Measure Description: Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.
[2]
Measure Analysis Population Description: All randomized participants who had baseline CDI score.
Multidimensional Anxiety Scale for Children (MASC)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Physical Symptoms Number Analyzed 89 participants 89 participants 178 participants
13.6  (7.3) 13.6  (7.6) 13.6  (7.5)
Harm Avoidance Number Analyzed 89 participants 89 participants 178 participants
15.0  (4.2) 14.4  (4.7) 14.7  (4.5)
Social Anxiety Number Analyzed 89 participants 89 participants 178 participants
9.8  (6.3) 9.8  (6.3) 9.8  (6.6)
Separation/Panic Number Analyzed 89 participants 89 participants 178 participants
6.7  (4.9) 6.0  (4.5) 6.4  (4.7)
Total Score Number Analyzed 89 participants 89 participants 178 participants
45.1  (16.6) 43.9  (18.7) 44.5  (17.65)
[1]
Measure Description:

MASC consists of 39 items that comprise 4 factors. Each item is scored on a 0 to 3-point scale (0-never to 3-often).

  1. Physical symptoms (tense/restless and somatic/autonomic) - 12 items with score range 0 to 36.
  2. Social anxiety (humiliation/rejection and public performance fears) - 9 items with score range of 0 to 27.
  3. Harm avoidance (perfectionism and anxious coping) - 9 items with score range of 0 to 27.
  4. Separation anxiety - 9 items with score range of 0 to 27. Total score ranges from 0 to 117. Higher the total score, the more severe the anxiety.
[2]
Measure Analysis Population Description: All randomized participants who had baseline MASC score.
1.Primary Outcome
Title Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
Hide Description

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square (LS) means.

Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.
Arm/Group Title Duloxetine - Acute Placebo - Acute
Hide Arm/Group Description:
Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
Participants received Placebo orally once daily (QD) for 13 weeks.
Overall Number of Participants Analyzed 76 76
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.62  (0.247) -0.97  (0.244)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean change difference
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-1.30 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.330
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items
Hide Description

The Brief Pain Inventory (BPI) - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.

MMRM model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce LS means.

Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI severity & interferences items score.
Arm/Group Title Duloxetine - Acute Placebo - Acute
Hide Arm/Group Description:
Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
Participants received Placebo orally once daily (QD) for 13 weeks.
Overall Number of Participants Analyzed 76 76
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Worst Pain -1.58  (0.270) -0.90  (0.266)
Least Pain -1.08  (0.239) -0.47  (0.236)
Pain Right Now -1.56  (0.274) -1.05  (0.271)
General Activity -2.00  (0.262) -1.03  (0.258)
Mood -2.00  (0.269) -1.46  (0.265)
Walking ability -1.30  (0.266) -1.09  (0.262)
Normal Work -1.49  (0.277) -1.21  (0.274)
Relations With Other People -1.87  (0.237) -1.07  (0.233)
Sleep -1.40  (0.343) -1.05  (0.338)
Enjoyment of Life -1.76  (0.253) -1.47  (0.250)
School Work -1.68  (0.316) -1.08  (0.313)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Worst Pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .059
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-1.40 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.360
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Least Pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-1.24 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.319
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Pain Right Now
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .165
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.51
Confidence Interval (2-Sided) 95%
-1.23 to 0.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.365
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments General Activity
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.97
Confidence Interval (2-Sided) 95%
-1.65 to -0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.344
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Mood
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .128
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-1.25 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.356
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Walking ability
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .560
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.90 to 0.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.352
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Normal Work
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-1.01 to 0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.371
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Relations With Other
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .011
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-1.42 to -0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.312
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Sleep
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .443
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-1.25 to 0.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.454
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Enjoyment of Life
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .390
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.96 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.338
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments School Work
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .160
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-1.44 to 0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.424
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Maintenance Effect in Acute Phase Responders on the Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
Hide Description

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function.Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Acute phase responders: Participants with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase.

Time Frame Baseline (Extension Phase), 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in duloxetine only arm with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase.
Arm/Group Title Duloxetine/Duloxetine - Extension
Hide Arm/Group Description:
Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment phase.
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.4  (1.24)
4.Secondary Outcome
Title Number of Participants With Greater Than or Equal to 30% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks
Hide Description

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF).

Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.
Arm/Group Title Duloxetine - Acute Placebo - Acute
Hide Arm/Group Description:
Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
Participants received Placebo orally once daily (QD) for 13 weeks.
Overall Number of Participants Analyzed 90 91
Measure Type: Count of Participants
Unit of Measure: Participants
47
  52.2%
33
  36.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .051
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Greater Than or Equal to 50% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks
Hide Description

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF).

Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.
Arm/Group Title Duloxetine - Acute Placebo - Acute
Hide Arm/Group Description:
Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
Participants received Placebo orally once daily (QD) for 13 weeks.
Overall Number of Participants Analyzed 90 91
Measure Type: Count of Participants
Unit of Measure: Participants
36
  40.0%
22
  24.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .038
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores
Hide Description

Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for “pain now,” worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.

Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline PPQ score.
Arm/Group Title Duloxetine - Acute Placebo - Acute
Hide Arm/Group Description:
Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
Participants received Placebo orally once daily (QD) for 13 weeks.
Overall Number of Participants Analyzed 87 86
Least Squares Mean (Standard Error)
Unit of Measure: mm
Average Pain Score -11.03  (2.982) -9.41  (2.946)
Worst Pain Score -14.36  (3.367) -8.46  (3.322)
Pain Score Right Now -8.99  (3.092) -7.20  (3.065)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Average Pain Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .669
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.62
Confidence Interval (2-Sided) 95%
-9.10 to 5.86
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Worst Pain Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .169
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.90
Confidence Interval (2-Sided) 95%
-14.32 to 2.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Pain Score Right Now
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .647
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.79
Confidence Interval (2-Sided) 95%
-9.53 to 5.94
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score
Hide Description

Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value.

Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CGI-S overall illness score.
Arm/Group Title Duloxetine - Acute Placebo - Acute
Hide Arm/Group Description:
Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
Participants received Placebo orally once daily (QD) for 13 weeks.
Overall Number of Participants Analyzed 90 92
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.88  (0.121) -0.66  (0.118)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .146
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.52 to 0.08
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score
Hide Description

Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value.

Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CGI-S mental illness score.
Arm/Group Title Duloxetine - Acute Placebo - Acute
Hide Arm/Group Description:
Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
Participants received Placebo orally once daily (QD) for 13 weeks.
Overall Number of Participants Analyzed 90 92
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.16  (0.089) -0.15  (0.087)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .927
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.23 to 0.21
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Functional Disability Inventory Child Form (FDI-Child)
Hide Description

Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.

Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline FDI child scale score.
Arm/Group Title Duloxetine - Acute Placebo - Acute
Hide Arm/Group Description:
Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
Participants received Placebo orally once daily (QD) for 13 weeks.
Overall Number of Participants Analyzed 87 88
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.97  (1.038) -5.00  (1.021)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .431
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
-1.54 to 3.59
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent)
Hide Description

Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.

Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline FDI-parent scale score.
Arm/Group Title Duloxetine - Acute Placebo - Acute
Hide Arm/Group Description:
Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
Participants received Placebo orally once daily (QD) for 13 weeks.
Overall Number of Participants Analyzed 86 87
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.25  (1.152) -4.17  (1.139)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .529
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
-1.95 to 3.79
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Children's Depression Inventory (CDI)
Hide Description

Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.

Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CDI score.
Arm/Group Title Duloxetine - Acute Placebo - Acute
Hide Arm/Group Description:
Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
Participants received Placebo orally once daily (QD) for 13 weeks.
Overall Number of Participants Analyzed 89 89
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.28  (0.682) -2.45  (0.674)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .335
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-2.52 to 0.86
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)
Hide Description Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Time Frame Baseline, 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline MASC score.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.

Arm/Group Title Duloxetine - Acute Placebo - Acute
Hide Arm/Group Description:
Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.
Participants received Placebo orally once daily (QD) for 13 weeks.
Overall Number of Participants Analyzed 89 89
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Physical Symptoms -1.39  (0.663) -1.44  (0.652)
Harm Avoidance -1.34  (0.507) -0.78  (0.501)
Social Anxiety -1.86  (0.497) -1.42  (0.489)
Separation/Panic -1.62  (0.393) -1.43  (0.389)
Total Score -6.21  (1.575) -4.99  (1.558)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Physical Symptoms Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .955
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .05
Confidence Interval (2-Sided) 95%
-1.59 to 1.68
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Harm Avoidance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .381
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-1.82 to 0.70
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Social Anxiety
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .486
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-1.66 to 0.79
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Separation/Panic
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .700
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-1.17 to 0.79
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine - Acute, Placebo - Acute
Comments Total Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .540
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-5.12 to 2.69
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items
Hide Description

The BPI - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.

Time Frame Baseline (extension phase), 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline BPI severity & interferences items scores.

Baseline for extension phase is defined as the last non-missing value in acute phase.

Arm/Group Title Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
Hide Arm/Group Description:
Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Overall Number of Participants Analyzed 74 75
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Worst Pain -0.65  (0.262) -0.80  (0.256)
Least Pain -0.29  (0.218) -0.45  (0.212)
Pain Right Now -0.38  (0.259) -0.29  (0.252)
General Activity -0.18  (0.233) 0.20  (0.229)
Mood -0.15  (0.270) -0.25  (0.258)
Walking Ability -0.24  (0.260) -0.21  (0.253)
Normal Work -0.62  (0.231) -0.32  (0.226)
Relations with Other People -0.12  (0.229) -0.41  (0.222)
Sleep -0.63  (0.292) -0.54  (0.284)
Enjoyment of Life -0.25  (0.243) -0.26  (0.236)
School Work -0.59  (0.278) -0.06  (0.271)
14.Secondary Outcome
Title Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores
Hide Description

Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.

Time Frame Baseline (extension phase), 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline PPQ measurement.

Baseline for extension phase is defined as the last non-missing value in acute phase.

Arm/Group Title Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
Hide Arm/Group Description:
Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Overall Number of Participants Analyzed 68 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Average Pain Score -10.65  (3.080) -6.44  (3.296)
Worst Pain Score -4.15  (3.127) -8.06  (3.677)
Score Right Now -4.74  (3.075) -6.34  (3.335)
15.Secondary Outcome
Title Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score
Hide Description

Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value.

Time Frame Baseline (extension phase), 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CGI overall illness measurement.

Baseline for extension phase is defined as the last non-missing value in acute phase.

Arm/Group Title Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
Hide Arm/Group Description:
Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Overall Number of Participants Analyzed 74 75
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.67  (0.125) -0.67  (0.121)
16.Secondary Outcome
Title Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score
Hide Description

Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value.

Time Frame Baseline (extension phase), 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CGI mental Illness measurement.

Baseline for extension phase is defined as the last non-missing value in acute phase.

Arm/Group Title Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
Hide Arm/Group Description:
Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Overall Number of Participants Analyzed 74 75
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.20  (0.104) -0.24  (0.101)
17.Secondary Outcome
Title Change From Baseline in Functional Disability Inventory Child Form (FDI-child)
Hide Description

Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.

Time Frame Baseline (extension phase), 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline FDI-child measurement.

Baseline for extension phase is defined as the last non-missing value in acute phase.

Arm/Group Title Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
Hide Arm/Group Description:
Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Overall Number of Participants Analyzed 67 62
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.71  (1.202) -1.03  (1.267)
18.Secondary Outcome
Title Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent)
Hide Description

Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.

Time Frame Baseline (extension phase), 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline FDI-parent measurement.

Baseline for extension phase is defined as the last non-missing value in acute phase.

Arm/Group Title Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
Hide Arm/Group Description:
Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Overall Number of Participants Analyzed 68 60
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.49  (1.227) -2.27  (1.327)
19.Secondary Outcome
Title Change From Baseline in Children's Depression Inventory (CDI)
Hide Description

Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.

Time Frame Baseline (extension phase), 39 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CDI measurement.

Baseline for extension phase is defined as the last non-missing value in acute phase.

Arm/Group Title Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
Hide Arm/Group Description:
Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Overall Number of Participants Analyzed 74 74
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.42  (0.703) -1.41  (0.681)
20.Secondary Outcome
Title Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)
Hide Description Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.ANCOVA model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Time Frame Baseline (extension phase), 39 weeks
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Hide Analysis Population Description

All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline MASC measurement.

Baseline for extension phase is defined as the last non-missing value in acute phase.

Arm/Group Title Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
Hide Arm/Group Description:
Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
Overall Number of Participants Analyzed 74 74
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Physical Symptoms -0.63  (0.715) -0.92  (0.692)
Harm Avoidance 0.23  (0.485) 0.10  (0.471)
Social Anxiety -0.11  (0.487) -0.02  (0.472)
Separation/Panic -0.06  (0.371) 0.01  (0.361)
Total Score -0.55  (1.478) -0.78  (1.432)
Time Frame up to 39 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine - Acute Placebo - Acute Duloxetine/Duloxetine - Extension Placebo/Duloxetine - Extension Duloxetine 60/Duloxetine 30 - Taper Placebo/Placebo - Taper
Hide Arm/Group Description Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks during Acute phase. Participants received Placebo orally once daily (QD) for 13 weeks during Acute phase. Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase). Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase). Participants who received 60mg Duloxetine in acute & extension phase received 30mg of Duloxetine in taper phase. Participants who received placebo or 30mg Duloxetine in acute phase received placebo in Taper phase.
All-Cause Mortality
Duloxetine - Acute Placebo - Acute Duloxetine/Duloxetine - Extension Placebo/Duloxetine - Extension Duloxetine 60/Duloxetine 30 - Taper Placebo/Placebo - Taper
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/91 (0.00%)      0/93 (0.00%)      0/74 (0.00%)      0/75 (0.00%)      0/77 (0.00%)      0/3 (0.00%)    
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Duloxetine - Acute Placebo - Acute Duloxetine/Duloxetine - Extension Placebo/Duloxetine - Extension Duloxetine 60/Duloxetine 30 - Taper Placebo/Placebo - Taper
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/91 (2.20%)      0/93 (0.00%)      3/74 (4.05%)      3/75 (4.00%)      0/77 (0.00%)      0/3 (0.00%)    
Infections and infestations             
Appendicitis  1  1/91 (1.10%)  1 0/93 (0.00%)  0 1/74 (1.35%)  1 0/75 (0.00%)  0 0/77 (0.00%)  0 0/3 (0.00%)  0
Injury, poisoning and procedural complications             
Intentional overdose  1  0/91 (0.00%)  0 0/93 (0.00%)  0 0/74 (0.00%)  0 1/75 (1.33%)  1 0/77 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders             
Generalised tonic-clonic seizure  1  0/91 (0.00%)  0 0/93 (0.00%)  0 0/74 (0.00%)  0 1/75 (1.33%)  1 0/77 (0.00%)  0 0/3 (0.00%)  0
Psychiatric disorders             
Affective disorder  1  0/91 (0.00%)  0 0/93 (0.00%)  0 0/74 (0.00%)  0 1/75 (1.33%)  1 0/77 (0.00%)  0 0/3 (0.00%)  0
Hallucination, auditory  1  0/91 (0.00%)  0 0/93 (0.00%)  0 0/74 (0.00%)  0 1/75 (1.33%)  1 0/77 (0.00%)  0 0/3 (0.00%)  0
Intentional self-injury  1  0/91 (0.00%)  0 0/93 (0.00%)  0 0/74 (0.00%)  0 1/75 (1.33%)  1 0/77 (0.00%)  0 0/3 (0.00%)  0
Suicidal ideation  1  1/91 (1.10%)  1 0/93 (0.00%)  0 0/74 (0.00%)  0 1/75 (1.33%)  1 0/77 (0.00%)  0 0/3 (0.00%)  0
Suicide attempt  1  0/91 (0.00%)  0 0/93 (0.00%)  0 2/74 (2.70%)  2 0/75 (0.00%)  0 0/77 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Duloxetine - Acute Placebo - Acute Duloxetine/Duloxetine - Extension Placebo/Duloxetine - Extension Duloxetine 60/Duloxetine 30 - Taper Placebo/Placebo - Taper
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/91 (81.32%)      58/93 (62.37%)      52/74 (70.27%)      54/75 (72.00%)      7/77 (9.09%)      0/3 (0.00%)    
Gastrointestinal disorders             
Abdominal pain  1  0/91 (0.00%)  0 2/93 (2.15%)  2 0/74 (0.00%)  0 4/75 (5.33%)  6 0/77 (0.00%)  0 0/3 (0.00%)  0
Abdominal pain upper  1  2/91 (2.20%)  2 6/93 (6.45%)  6 2/74 (2.70%)  2 6/75 (8.00%)  8 0/77 (0.00%)  0 0/3 (0.00%)  0
Constipation  1  2/91 (2.20%)  3 2/93 (2.15%)  2 2/74 (2.70%)  2 4/75 (5.33%)  4 0/77 (0.00%)  0 0/3 (0.00%)  0
Nausea  1  23/91 (25.27%)  30 14/93 (15.05%)  16 10/74 (13.51%)  14 22/75 (29.33%)  26 0/77 (0.00%)  0 0/3 (0.00%)  0
Vomiting  1  14/91 (15.38%)  19 5/93 (5.38%)  5 4/74 (5.41%)  4 8/75 (10.67%)  9 0/77 (0.00%)  0 0/3 (0.00%)  0
General disorders             
Fatigue  1  5/91 (5.49%)  5 2/93 (2.15%)  2 4/74 (5.41%)  4 2/75 (2.67%)  2 0/77 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations             
Gastroenteritis viral  1  5/91 (5.49%)  6 0/93 (0.00%)  0 1/74 (1.35%)  1 4/75 (5.33%)  5 0/77 (0.00%)  0 0/3 (0.00%)  0
Nasopharyngitis  1  8/91 (8.79%)  11 2/93 (2.15%)  2 3/74 (4.05%)  3 4/75 (5.33%)  4 1/77 (1.30%)  1 0/3 (0.00%)  0
Upper respiratory tract infection  1  6/91 (6.59%)  6 2/93 (2.15%)  2 6/74 (8.11%)  6 4/75 (5.33%)  4 1/77 (1.30%)  1 0/3 (0.00%)  0
Metabolism and nutrition disorders             
Decreased appetite  1  14/91 (15.38%)  14 3/93 (3.23%)  5 6/74 (8.11%)  6 8/75 (10.67%)  9 0/77 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders             
Dizziness  1  8/91 (8.79%)  10 9/93 (9.68%)  13 4/74 (5.41%)  4 3/75 (4.00%)  4 3/77 (3.90%)  3 0/3 (0.00%)  0
Headache  1  13/91 (14.29%)  15 10/93 (10.75%)  14 6/74 (8.11%)  8 5/75 (6.67%)  9 1/77 (1.30%)  1 0/3 (0.00%)  0
Somnolence  1  8/91 (8.79%)  8 3/93 (3.23%)  3 3/74 (4.05%)  3 2/75 (2.67%)  2 1/77 (1.30%)  1 0/3 (0.00%)  0
Psychiatric disorders             
Insomnia  1  0/91 (0.00%)  0 3/93 (3.23%)  3 2/74 (2.70%)  2 4/75 (5.33%)  5 0/77 (0.00%)  0 0/3 (0.00%)  0
Reproductive system and breast disorders             
Dysmenorrhoea  1  2/73 (2.74%)  2 4/65 (6.15%)  6 2/61 (3.28%)  2 2/53 (3.77%)  5 0/60 (0.00%)  0 0/2 (0.00%)  0
Erectile dysfunction  1  0/18 (0.00%)  0 0/28 (0.00%)  0 1/13 (7.69%)  1 0/22 (0.00%)  0 0/17 (0.00%)  0 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01237587     History of Changes
Other Study ID Numbers: 14099
F1J-MC-HMGW ( Other Identifier: Eli Lilly and Company )
CTRI/2011/07/001866 ( Registry Identifier: Clinical Trials Registry India )
First Submitted: November 8, 2010
First Posted: November 9, 2010
Results First Submitted: May 25, 2018
Results First Posted: August 14, 2018
Last Update Posted: August 14, 2018