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Trial record 38 of 179 for:    "Panic Disorder"

Org 25935 Versus Placebo as Augmentation to Cognitive-behavioral Therapy to Treat Panic Disorder (P05705)

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: NCT00725725
Recruitment Status : Terminated
First Posted : July 30, 2008
Results First Posted : December 30, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Panic Disorder
Interventions Behavioral: Cognitive-behavioral therapy
Drug: Org 25935
Drug: Placebo
Enrollment 46
Recruitment Details Adult (18 to 65 years of age) male and female participants with a diagnosis of current panic disorder (PD; with or without agoraphobia [AGP]) were recruited.
Pre-assignment Details  
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Period Title: Overall Study
Started 14 15 17
Treated 11 15 14
Completed 10 11 12
Not Completed 4 4 5
Reason Not Completed
Adverse Event             1             3             2
Lost to Follow-up             2             0             2
Withdrawal by Subject             1             0             1
Protocol Violation             0             1             0
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo Total
Hide Arm/Group Description Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period. Total of all reporting groups
Overall Number of Baseline Participants 14 15 17 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 17 participants 46 participants
33.1  (9.9) 36.4  (8.9) 32.8  (10.8) 34.1  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 17 participants 46 participants
Female
9
  64.3%
9
  60.0%
13
  76.5%
31
  67.4%
Male
5
  35.7%
6
  40.0%
4
  23.5%
15
  32.6%
1.Primary Outcome
Title Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)
Hide Description The mean change in PDSS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).
Time Frame Screening and Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS assessments at Screening and EOT.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 10 14 13
Mean (Standard Deviation)
Unit of Measure: PDSS Score
Screening 11.5  (1.51) 15.8  (4.00) 17.1  (3.99)
EOT (Placebo n=12) 5.3  (1.49) 7.6  (4.62) 6.6  (4.29)
EOT - Screening (Placebo n=12) -6.2  (2.15) -8.2  (4.49) -10.4  (4.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3934
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5299
Confidence Interval (2-Sided) 95%
-2.0781 to 5.1380
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3515
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2667
Confidence Interval (2-Sided) 95%
-1.4665 to 4.0000
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in PDSS Score From Baseline to Visit 4
Hide Description The mean change in PDSS score from baseline (Screening) to Visit 4 (Day 22) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).
Time Frame Screening and Visit 4 (Day 22)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and PDSS scores at Screening and Visit 4.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 10 14 13
Mean (Standard Deviation)
Unit of Measure: PDSS Score
Screening 11.5  (1.51) 15.8  (4.00) 17.1  (3.99)
Visit 4 (4 mg O n= 9; 12 mg O n=12) 7.1  (4.08) 10.5  (4.56) 12.2  (4.00)
Visit 4 - Screening (4 mg O n= 9; 12 mg O n=12) -4.2  (3.70) -5.3  (4.03) -4.9  (4.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3597
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8246
Confidence Interval (2-Sided) 95%
-5.8307 to 2.1815
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7770
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4414
Confidence Interval (2-Sided) 95%
-3.5952 to 2.7124
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in PDSS Score From Baseline to Follow-Up
Hide Description The mean change in PDSS score from baseline (Screening) to Follow-Up (Day 59) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).
Time Frame Screening and Follow-Up (Day 59)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS scores at Screening and Follow-Up.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 10 14 13
Mean (Standard Deviation)
Unit of Measure: PDSS Score
Screening 11.5  (1.51) 15.8  (4.00) 17.1  (3.99)
Follow-Up (12 mg O, Placebo n=12) 4.8  (2.20) 7.4  (5.85) 5.3  (4.56)
Follow-Up - Screening (12 mg O, Placebo n=12) -6.7  (2.54) -8.3  (5.80) -11.7  (4.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2683
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.3356
Confidence Interval (2-Sided) 95%
-1.8933 to 6.5644
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0844
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.1317
Confidence Interval (2-Sided) 95%
-0.4518 to 6.7152
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening
Hide Description The SCID-I/P with Psy Screen, Panic Disorder Module was used to score participants' PD (with [w] or without [w/o] AGP) as being current (full criteria for the disorder met), in full remission (IFR) [there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder], or in partial remission (IPR) [full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain] at baseline (Screening). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at Screening.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 10 14 13
Measure Type: Number
Unit of Measure: Participants
PD w AGP: Current 9 12 12
PD w/o AGP: Current 1 2 1
5.Secondary Outcome
Title SCID-I/P With Psy Screen Score at EOT
Hide Description The SCID-I/P with Psy Screen, Panic Disorder Module, was used to score participants' PD (w or w/o AP) as being current (full criteria for the disorder are met), IFR (there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder), or IPR (full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain) at EOT (Day 36). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.
Time Frame Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at EOT.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 10 13 12
Measure Type: Number
Unit of Measure: Participants
PD w AGP: Current 3 4 6
PD w AGP: IFR 0 1 0
PD w AGP: IPR 4 4 5
PD w/o AGP: Current 1 3 0
PD w/o AGP: IFR 0 0 1
PD w/o AGP: IPR 2 1 0
6.Secondary Outcome
Title Change in Clinical Global Impression-Severity (CGI-S) Score
Hide Description The mean change in CGI-S score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The CGI-S is a clinician-rated instrument used to assess global severity of general anxiety symptoms. The instrument consists of a 7-point scale that the clinician uses to rate the severity of the patient's illness, from 1 (normal, not at all ill) to 7 (extremely ill).
Time Frame Screening and Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had CGI-S scores at Screening and EOT.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 10 14 13
Mean (Standard Deviation)
Unit of Measure: CGI-S Score
Screening 4.0  (0.0) 4.6  (0.74) 4.8  (0.83)
EOT (Placebo n=12) 2.8  (0.42) 3.1  (0.92) 3.0  (1.13)
EOT - Screening (Placebo n=12) -1.2  (0.42) -1.6  (0.85) -1.8  (0.97)
7.Secondary Outcome
Title Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score
Hide Description The mean change in SIGH-A score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The SIGH-A is a 14-item scale to assess anxiety in a clinical population. Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of zero to a maximum of 56 (higher scores indicate greater anxiety severity).
Time Frame Screening and Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SIGH-A scores at Screening and EOT.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 10 14 13
Mean (Standard Deviation)
Unit of Measure: SIGH-A Score
Screening 17.2  (8.42) 14.3  (6.37) 14.6  (9.14)
EOT (12 mg O n=13; Placebo n=12) 9.7  (7.21) 10.0  (6.43) 8.5  (6.96)
EOT - Screening (12 mg O n=13; Placebo n=12) -7.5  (7.37) -3.8  (5.97) -6.4  (7.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8894
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3456
Confidence Interval (2-Sided) 95%
-4.6211 to 5.3124
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3765
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.0417
Confidence Interval (2-Sided) 95%
-2.5526 to 6.6360
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Anxiety Sensitivity Index (ASI) Score
Hide Description The mean change in ASI score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The ASI is a 16-item self-report questionnaire that assesses fear of anxiety sensations. Each item is scored on a 5-point Likert scale (0 to 4) with total score ranging from a minimum of 0 to a maximum of 64 (higher scores indicate greater fear of anxiety sensations).
Time Frame Screening and Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had ASI scores at Screening and EOT.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 10 14 12
Mean (Standard Deviation)
Unit of Measure: ASI Score
Screening 31.1  (9.92) 37.1  (9.56) 37.5  (12.91)
EOT (12 mg O n=13) 20.1  (10.29) 26.3  (10.56) 24.8  (13.95)
EOT - Screening (Placebo n=11) -11.0  (10.23) -10.8  (14.48) -13.8  (13.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8073
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2502
Confidence Interval (2-Sided) 95%
-11.4963 to 8.9958
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6610
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.0291
Confidence Interval (2-Sided) 95%
-7.2132 to 11.2714
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score
Hide Description The mean change in MADRS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The MADRS is a 10-item clinical-administered scale designed to assess severity of depression. Each item is rated from 0 to 6, with total score ranging from 0 to 60 (higher MADRS scores indicate more severe depression).
Time Frame Screening and Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had MADRS scores at Screening and EOT.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 10 14 13
Mean (Standard Deviation)
Unit of Measure: MADRS score
Screening 12.4  (8.03) 11.1  (6.38) 14.2  (9.20)
EOT (12 mg O n=13, Placebo n=12) 6.6  (4.33) 7.0  (6.98) 6.3  (5.12)
EOT - Screening (12 mg O n=13, Placebo n=12) -5.8  (6.76) -4.2  (5.06) -7.8  (8.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7895
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.7296
Confidence Interval (2-Sided) 95%
-4.7291 to 6.1883
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5488
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5260
Confidence Interval (2-Sided) 95%
-3.5495 to 6.6015
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score
Hide Description The mean change in Q-LES-Q score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The Q-LES-Q is a self-report questionnaire rating 16 aspects of quality of life, including physical health and mood. Scores range from 0 ("very poor") to 5 ("very good"), with total score ranging from 0 to 80 (higher O-LES-Q scores indicate greater quality of life).
Time Frame Screening and Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had Q-LES-Q scores at Screening and EOT.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 10 14 12
Mean (Standard Deviation)
Unit of Measure: Q-LES-Q Score
Screening 49.8  (6.20) 47.2  (8.88) 45.3  (11.63)
EOT (12 mg O n=11) 56.6  (3.20) 50.5  (9.32) 55.3  (7.69)
EOT - Screening (12 mg O n=11, Placebo n=11) 6.8  (5.39) 3.7  (5.06) 10.8  (11.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6516
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2766
Confidence Interval (2-Sided) 95%
-6.9269 to 4.3738
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 mg Org 25935, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0256
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.1867
Confidence Interval (2-Sided) 95%
-11.5864 to -0.7869
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants Experiencing an Adverse Event (AE)
Hide Description The number of participants experiencing one or more AEs throughout the study period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 59 days
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included in the safety analysis.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 11 15 14
Measure Type: Number
Unit of Measure: Participants
8 12 5
12.Secondary Outcome
Title Number of Participants Discontinuing Study Therapy Due to AEs
Hide Description The number of participants withdrawing from study treatment during the treatment period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants are included in the safety analysis.
Arm/Group Title 4 mg Org 25935 12 mg Org 25935 Placebo
Hide Arm/Group Description:
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Overall Number of Participants Analyzed 11 15 14
Measure Type: Number
Unit of Measure: Participants
1 3 1
Time Frame Up to 59 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Org 25935 4 mg Org 25935 12 mg Placebo
Hide Arm/Group Description Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
All-Cause Mortality
Org 25935 4 mg Org 25935 12 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Org 25935 4 mg Org 25935 12 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/15 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Org 25935 4 mg Org 25935 12 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/11 (72.73%)      12/15 (80.00%)      5/14 (35.71%)    
Blood and lymphatic system disorders       
Neutropenia  1  1/11 (9.09%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0
Cardiac disorders       
Palpitations  1  1/11 (9.09%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0
Tachycardia  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Ear and labyrinth disorders       
Tinnitus  1  1/11 (9.09%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0
Vertigo  1  0/11 (0.00%)  0 3/15 (20.00%)  4 0/14 (0.00%)  0
Eye disorders       
Dry eye  1  0/11 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  3
Mydriasis  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Photophobia  1  0/11 (0.00%)  0 1/15 (6.67%)  1 1/14 (7.14%)  1
Photopsia  1  0/11 (0.00%)  0 1/15 (6.67%)  3 0/14 (0.00%)  0
Vision blurred  1  0/11 (0.00%)  0 2/15 (13.33%)  3 1/14 (7.14%)  1
Visual brightness  1  0/11 (0.00%)  0 2/15 (13.33%)  2 0/14 (0.00%)  0
Visual impairment  1  1/11 (9.09%)  1 4/15 (26.67%)  4 0/14 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain upper  1  1/11 (9.09%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0
Diarrhoea  1  0/11 (0.00%)  0 2/15 (13.33%)  2 0/14 (0.00%)  0
Nausea  1  0/11 (0.00%)  0 5/15 (33.33%)  7 0/14 (0.00%)  0
General disorders       
Chills  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Fatigue  1  1/11 (9.09%)  1 2/15 (13.33%)  3 1/14 (7.14%)  1
Feeling abnormal  1  0/11 (0.00%)  0 1/15 (6.67%)  1 1/14 (7.14%)  2
Feeling jittery  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Irritability  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Pyrexia  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Immune system disorders       
Seasonal allergy  1  1/11 (9.09%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0
Infections and infestations       
Bronchitis  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Otitis media  1  0/11 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1
Metabolism and nutrition disorders       
Hypoglycaemia  1  1/11 (9.09%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0
Nervous system disorders       
Balance disorder  1  0/11 (0.00%)  0 1/15 (6.67%)  3 0/14 (0.00%)  0
Disturbance in attention  1  0/11 (0.00%)  0 1/15 (6.67%)  2 0/14 (0.00%)  0
Dizziness  1  2/11 (18.18%)  4 7/15 (46.67%)  13 0/14 (0.00%)  0
Headache  1  1/11 (9.09%)  1 4/15 (26.67%)  4 0/14 (0.00%)  0
Hypoaesthesia  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Migraine  1  1/11 (9.09%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0
Paraesthesia  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Somnolence  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Psychiatric disorders       
Anxiety  1  1/11 (9.09%)  1 1/15 (6.67%)  1 1/14 (7.14%)  1
Derealisation  1  0/11 (0.00%)  0 2/15 (13.33%)  3 0/14 (0.00%)  0
Dissociation  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Nightmare  1  1/11 (9.09%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0
Panic attack  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Restlessness  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Thinking abnormal  1  0/11 (0.00%)  0 1/15 (6.67%)  2 0/14 (0.00%)  0
Reproductive system and breast disorders       
Dysmenorrhoea  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dry throat  1  0/11 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  3
Nasal congestion  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Oropharyngeal pain  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Sinus congestion  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Yawning  1  1/11 (9.09%)  3 0/15 (0.00%)  0 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  0/11 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Rash  1  0/11 (0.00%)  0 2/15 (13.33%)  3 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Senior Vice President, Global Clinical Develpment
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725725     History of Changes
Other Study ID Numbers: P05705
MK-8435-002 ( Other Identifier: Merck Protocol )
Org 172012 ( Other Identifier: Organon Protocol )
First Submitted: July 28, 2008
First Posted: July 30, 2008
Results First Submitted: August 10, 2016
Results First Posted: December 30, 2016
Last Update Posted: October 16, 2018