Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

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: NCT00667446
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : December 10, 2013
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Precocious
Leuprolide Acetate
Luteinizing Hormone (LH)
Gonadotrophin-releasing Hormone Agonist (GnRHa)
Tanner Staging
Depot Formulation
Suppression of LH
Central Precocious Puberty (CPP)
Gonadotrophin-releasing Hormone (GnRH)
Lupron
GnRH Analog
Pediatrics Central Precocious Puberty
Intervention Drug: Leuprolide Acetate 3 Month Depot
Enrollment 72
Recruitment Details Participants who successfully completed and showed maintenance of luteinizing hormone suppression through the 6-month treatment period of the lead-in study L-CP07-167 (NCT00635817) received the same treatment in this study that they were previously assigned in the lead-in study.
Pre-assignment Details At the end of the Treatment Period, participants who completed the study or prematurely discontinued from the study could enter the Safety Follow-Up Period.
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Hide Arm/Group Description Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator. Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
Period Title: Treatment Period (36 Months)
Started 34 38
Completed 11 13
Not Completed 23 25
Reason Not Completed
Ready to enter puberty based on age             13             15
Other             2             2
Personal reasons             2             2
Withdrawal by Subject             0             4
Not Adequately Suppressed on Therapy             3             0
Lost to Follow-up             1             0
Protocol Violation             1             1
Therapeutic Failure             1             1
Period Title: Safety Follow-up Period (12 Weeks)
Started 28 26
Completed 28 25
Not Completed 0 1
Reason Not Completed
No Longer Needed Treatment             0             1
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg Total
Hide Arm/Group Description Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart. Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart. Total of all reporting groups
Overall Number of Baseline Participants 34 38 72
Hide Baseline Analysis Population Description
Participants who received at least 1 dose of study drug in this extension study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 38 participants 72 participants
8.50  (1.71) 8.45  (1.52) 8.47  (1.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 38 participants 72 participants
Female
32
  94.1%
33
  86.8%
65
  90.3%
Male
2
   5.9%
5
  13.2%
7
   9.7%
1.Primary Outcome
Title Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
Hide Description Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.
Time Frame Day 1, Months 6, 12, 24, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat, defined as patients who received at least 1 dose of study drug with at least 1 post-baseline measurement of any maintenance of suppression variable, & did not prematurely discontinue in the 1st 30 days due to inadequate suppression at Month 6 of the lead-in study. N= the number of patients with available data at each time point.
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Hide Arm/Group Description:
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed 33 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 1 [N= 32, 37]
96.9
(83.78 to 99.92)
100.0
(90.51 to 100.00)
Month 6 [N=32, 36]
93.8
(79.19 to 99.23)
100.0
(90.26 to 100.00)
Month 12 [N=31, 32]
90.3
(74.25 to 97.96)
96.9
(83.78 to 99.92)
Month 24 [N=16, 18]
87.5
(64.65 to 98.45)
100.0
(81.47 to 100.00)
Month 36 [N=9, 11]
77.8
(39.99 to 97.19)
100.0
(71.51 to 100.00)
Final Visit [N=33, 36]
93.9
(79.77 to 99.26)
100.0
(90.26 to 100.00)
2.Secondary Outcome
Title Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
Hide Description

The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.

The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36.

Time Frame Day 1, Months 3, 6, 9, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat female population. N = the number of participants with available data at each time point.
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Hide Arm/Group Description:
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed 31 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 1 [N=28, 30]
96.4
(81.65 to 99.91)
100.0
(88.43 to 100.00)
Month 3 [N=29, 33]
100.0
(88.06 to 100.00)
100.0
(89.42 to 100.00)
Month 6 [N=26, 25]
100.0
(86.77 to 100.00)
100.0
(86.28 to 100.00)
Month 9 [N=18, 18]
100.0
(81.47 to 100.00)
100.0
(81.47 to 100.00)
Month 12 [N=10, 12]
100.0
(69.15 to 100.00)
100.0
(73.54 to 100.00)
Month 24 [N=1, 0]
100.0
(2.50 to 100.00)
NA [1] 
(NA to NA)
Final Visit [N=31, 33]
100.0
(88.78 to 100.00)
100.0
(89.42 to 100.00)
[1]
No participants with available data at this time point
3.Secondary Outcome
Title Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
Hide Description

The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.

The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36.

Time Frame Months 6, 9, 12, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat female population. N = the number of participants with available data at each time point.
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Hide Arm/Group Description:
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed 31 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 6 [N=4, 6]
100.0
(39.76 to 100.00)
83.3
(35.88 to 99.58)
Month 9 [N=13, 10]
61.5
(31.58 to 86.14)
40.0
(12.16 to 73.76)
Month 12 [N=20, 15]
45.0
(23.06 to 68.47)
60.0
(32.29 to 83.66)
Month 24 [N=14, 15]
50.0
(23.04 to 76.96)
53.3
(26.59 to 78.73)
Month 30 [N=9, 15]
33.3
(7.49 to 70.07)
26.7
(7.79 to 55.10)
Month 36 [N=7, 11]
28.6
(3.67 to 70.96)
36.4
(10.93 to 69.21)
Final Visit [N=24, 26]
29.2
(12.62 to 51.09)
30.8
(14.33 to 51.79)
4.Secondary Outcome
Title Percentage of Male Participants With Suppression of Basal Testosterone
Hide Description The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone < 30 ng/dL. Final visit is the participant's last visit closest to Month 36.
Time Frame Day 1, Months 3, 6, 9, 12, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat male population. N = the number of participants with available data at each time point.
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Hide Arm/Group Description:
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed 2 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 1 [N= 2, 5]
100.0
(15.81 to 100.00)
100.0
(47.82 to 100.00)
Month 3 [N=2, 5]
100.0
(15.81 to 100.00)
100.0
(47.82 to 100.00)
Month 6 [N=2, 5]
100.0
(15.81 to 100.00)
80.0
(28.36 to 99.49)
Month 9 [N=2, 5]
100.0
(15.81 to 100.00)
80.0
(28.36 to 99.49)
Month 12 [N=1, 5]
100.0
(2.50 to 100.00)
100.0
(47.82 to 100.00)
Month 24 [N=1, 3]
100.0
(2.50 to 100.00)
66.7
(9.43 to 99.16)
Month 30 [N=0, 1]
NA [1] 
(NA to NA)
100.0
(2.50 to 100.00)
Month 36 [N=0, 1]
NA [1] 
(NA to NA)
100.0
(2.50 to 100.00)
Final Visit [N=2, 5]
100.0
(15.81 to 100.00)
100.0
(47.82 to 100.00)
[1]
No participants with available data at this time point
5.Secondary Outcome
Title Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
Hide Description Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36.
Time Frame Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat. N = the number of participants with available data at each time point.
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Hide Arm/Group Description:
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed 33 38
Mean (Standard Deviation)
Unit of Measure: mIU/mL
Baseline [N=33, 38] 21.89  (38.46) 10.16  (12.66)
Day 1 [N=32, 37] 2.00  (1.03) 1.49  (0.86)
Month 6 [N=32, 36] 2.22  (1.16) 1.62  (0.82)
Month 12 [N=31, 32] 2.24  (1.20) 1.58  (1.02)
Month 24 [N=14, 18] 1.67  (0.97) 0.88  (0.58)
Month 36 [N=7, 11] 1.51  (0.85) 0.91  (0.49)
Final Visit [N=33, 36] 1.81  (1.13) 1.15  (0.74)
6.Secondary Outcome
Title Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Hide Description The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.
Time Frame Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat female population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Hide Arm/Group Description:
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 1 [N= 31, 31]
90.3
(74.2 to 98.0)
83.9
(66.3 to 94.5)
Month 3 [N=29, 31]
86.2
(68.3 to 96.1)
87.1
(70.2 to 96.4)
Month 6 [N=31, 30]
90.3
(74.2 to 98.0)
80.0
(61.4 to 92.3)
Month 9 [N=31, 28]
87.1
(70.2 to 96.4)
75.0
(55.1 to 89.3)
Month 12 [N=28, 26]
85.7
(67.3 to 96.0)
80.8
(60.6 to 93.4)
Month 18 [N=17, 20]
82.4
(56.6 to 96.2)
75.0
(50.9 to 91.3)
Month 24 [N=14, 16]
78.6
(49.2 to 95.3)
75.0
(47.6 to 92.7)
Month 30 [N=10, 16]
90.0
(55.5 to 99.7)
68.8
(41.3 to 89.0)
Month 36 [N=8, 12]
87.5
(47.3 to 99.7)
66.7
(34.9 to 90.1)
Final Visit [N=31, 31]
83.9
(66.3 to 94.5)
71.0
(52.0 to 85.8)
7.Secondary Outcome
Title Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Hide Description The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.
Time Frame Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat male population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Hide Arm/Group Description:
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed 2 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 1 [N= 2, 5]
50.0
(1.3 to 98.7)
40.0
(5.3 to 85.3)
Month 3 [N=2, 5]
50.0
(1.3 to 98.7)
60.0
(14.7 to 94.7)
Month 6 [N=2, 5]
50.0
(1.3 to 98.7)
60.0
(14.7 to 94.7)
Month 9 [N=2, 5]
50.0
(1.3 to 98.7)
40.0
(5.3 to 85.3)
Month 12 [N=1, 5]
100.0
(2.5 to 100.0)
60.0
(14.7 to 94.7)
Month 18 [N=1, 3]
100.0
(2.5 to 100.0)
100.0
(29.2 to 100.0)
Month 24 [N=1, 3]
100.0
(2.5 to 100.0)
33.3
(0.8 to 90.6)
Month 30 [N=1, 1]
100.0
(2.5 to 100.0)
100.0
(2.5 to 100.0)
Month 36 [N=0, 1]
NA [1] 
(NA to NA)
100.0
(2.5 to 100.0)
Final Visit [N=2, 5]
50.0
(1.3 to 98.7)
20.0
(0.5 to 71.6)
[1]
No participants with available data at this time point
8.Secondary Outcome
Title Change From Baseline in Growth Rate
Hide Description Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit.
Time Frame Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat with available growth rate data. N = participants with available data at each time point.
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Hide Arm/Group Description:
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed 32 38
Mean (Standard Deviation)
Unit of Measure: cm/year
Baseline [N=32, 38] 7.2  (3.96) 7.53  (2.81)
Change from Baseline at Day 1 [N=32, 38] -1.67  (3.90) -1.65  (3.43)
Change from Baseline at Month 6 [N=32, 37] -1.66  (3.78) -2.04  (2.95)
Change from Baseline at Month 12 [N=28, 32] -1.99  (3.90) -2.28  (2.88)
Change from Baseline at Month 18 [N=18, 23] -2.21  (4.29) -2.06  (2.40)
Change from Baseline at Month 24 [N=15, 19] -2.36  (4.85) -1.59  (2.20)
Change from Baseline at Month 30 [N=11, 17] -1.86  (5.45) -2.13  (2.33)
Change from Baseline at Month 36 [N=8, 13] -2.64  (5.93) -2.19  (2.41)
Change from Baseline at Final Visit [N=32, 38] -2.27  (3.78) -2.64  (2.65)
9.Secondary Outcome
Title Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
Hide Description

Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula:

(BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline).

Time Frame Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat with available bone age data. N = participants with available data at each time point.
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Hide Arm/Group Description:
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
Overall Number of Participants Analyzed 33 37
Mean (Standard Deviation)
Unit of Measure: ratio
Day 1 [N=32, 37] 0.51  (0.56) 1.02  (1.27)
Month 12 [N=32, 32] 0.52  (0.33) 0.62  (0.37)
Month 24 [N=14, 17] 0.53  (0.30) 0.72  (0.34)
Month 36 [N=5, 11] 0.43  (0.15) 0.64  (0.30)
Final Visit [N=33, 32] 0.48  (0.28) 0.56  (0.30)
Time Frame 37 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Hide Arm/Group Description Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart. Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
All-Cause Mortality
Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   1/34 (2.94%)   0/38 (0.00%) 
Nervous system disorders     
INTRACRANIAL PRESSURE INCREASED  1  1/34 (2.94%)  0/38 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Leuprolide Acetate 3M Depot 11.25 mg Leuprolide Acetate 3M Depot 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   31/34 (91.18%)   31/38 (81.58%) 
Ear and labyrinth disorders     
EAR PAIN  1  1/34 (2.94%)  2/38 (5.26%) 
Eye disorders     
MYOPIA  1  0/34 (0.00%)  2/38 (5.26%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  2/34 (5.88%)  3/38 (7.89%) 
ABDOMINAL PAIN UPPER  1  2/34 (5.88%)  3/38 (7.89%) 
CONSTIPATION  1  2/34 (5.88%)  1/38 (2.63%) 
DIARRHOEA  1  3/34 (8.82%)  2/38 (5.26%) 
NAUSEA  1  2/34 (5.88%)  1/38 (2.63%) 
VOMITING  1  0/34 (0.00%)  4/38 (10.53%) 
General disorders     
INJECTION SITE PAIN  1  10/34 (29.41%)  9/38 (23.68%) 
PYREXIA  1  6/34 (17.65%)  5/38 (13.16%) 
Immune system disorders     
SEASONAL ALLERGY  1  2/34 (5.88%)  1/38 (2.63%) 
Infections and infestations     
BODY TINEA  1  3/34 (8.82%)  0/38 (0.00%) 
BRONCHITIS  1  3/34 (8.82%)  0/38 (0.00%) 
EAR INFECTION  1  3/34 (8.82%)  1/38 (2.63%) 
GASTROENTERITIS  1  4/34 (11.76%)  4/38 (10.53%) 
INFLUENZA  1  3/34 (8.82%)  0/38 (0.00%) 
NASOPHARYNGITIS  1  3/34 (8.82%)  1/38 (2.63%) 
PHARYNGITIS  1  2/34 (5.88%)  1/38 (2.63%) 
PHARYNGITIS STREPTOCOCCAL  1  5/34 (14.71%)  4/38 (10.53%) 
SINUSITIS  1  2/34 (5.88%)  2/38 (5.26%) 
UPPER RESPIRATORY TRACT INFECTION  1  9/34 (26.47%)  5/38 (13.16%) 
Injury, poisoning and procedural complications     
EXCORIATION  1  0/34 (0.00%)  2/38 (5.26%) 
LIGAMENT SPRAIN  1  0/34 (0.00%)  2/38 (5.26%) 
Investigations     
WEIGHT INCREASED  1  0/34 (0.00%)  3/38 (7.89%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  4/34 (11.76%)  5/38 (13.16%) 
PAIN IN EXTREMITY  1  3/34 (8.82%)  3/38 (7.89%) 
Nervous system disorders     
HEADACHE  1  5/34 (14.71%)  6/38 (15.79%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  4/34 (11.76%)  9/38 (23.68%) 
NASAL CONGESTION  1  3/34 (8.82%)  5/38 (13.16%) 
RESPIRATORY DISORDER  1  1/34 (2.94%)  2/38 (5.26%) 
RHINORRHOEA  1  3/34 (8.82%)  1/38 (2.63%) 
Skin and subcutaneous tissue disorders     
ACNE  1  2/34 (5.88%)  2/38 (5.26%) 
ECZEMA  1  2/34 (5.88%)  1/38 (2.63%) 
RASH  1  3/34 (8.82%)  1/38 (2.63%) 
RASH PAPULAR  1  2/34 (5.88%)  0/38 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie, (prior sponsor, Abbott)
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00667446     History of Changes
Other Study ID Numbers: L-CP07-177
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: October 16, 2013
Results First Posted: December 10, 2013
Last Update Posted: January 9, 2014