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Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers

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: NCT01121913
Recruitment Status : Completed
First Posted : May 12, 2010
Results First Posted : August 16, 2010
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: Trazodone HCl
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trazodone Contramid® OAD (Prototype 1) First Trazodone Contramid® OAD (Prototype 2) First Triticco® First Desyrel® First
Hide Arm/Group Description 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase I; followed by 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase III; and 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases. 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase I, followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase II; 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase III; and 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases. 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase I; followed by 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases. 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase I; followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase II; 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
Period Title: First Intervention Period
Started 6 6 6 6
Completed 6 6 5 6
Not Completed 0 0 1 0
Reason Not Completed
Adverse Event             0             0             1             0
Period Title: First Washout Period
Started 6 6 5 6
Completed 5 6 5 6
Not Completed 1 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0
Period Title: Second Intervention Period
Started 5 6 5 6
Completed 5 6 4 6
Not Completed 0 0 1 0
Reason Not Completed
Adverse Event             0             0             1             0
Period Title: Second Washout Period
Started 5 6 4 6
Completed 5 6 3 6
Not Completed 0 0 1 0
Reason Not Completed
Withdrawal by Subject             0             0             1             0
Period Title: Third Intervention Period
Started 5 6 3 6
Completed 5 6 3 6
Not Completed 0 0 0 0
Period Title: Third Washout Period
Started 5 6 3 6
Completed 4 6 3 6
Not Completed 1 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0
Period Title: Fourth Intervention Period
Started 4 6 3 6
Completed 4 6 3 6
Not Completed 0 0 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive Trazodone Contramid® OAD (prototype 1) First, Trazodone Contramid® OAD (prototype 2) First, Triticco® First, and Desyrel® First.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
24.9  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
6
  25.0%
Male
18
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Africa Number Analyzed 24 participants
24
1.Primary Outcome
Title Bioequivalence Based on AUC(0-t)
Hide Description

AUC(0-t) = Area under the plasma concentration curve vs (versus) time data pairs, where t is the time of the last quantifiable concentration.

Measured in nanogram x hours per milliliter (ng*h/mL).

Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.
Arm/Group Title Trazodone Contramid® OAD (Prototype 1) Trazodone Contramid® OAD (Prototype 2) Triticco® Desyrel®
Hide Arm/Group Description:
1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
Overall Number of Participants Analyzed 19 19 19 19
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
33883  (8069) 32445  (8868) 32928  (8313) 31841  (7398)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 1), Triticco®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 102
Confidence Interval (2-Sided) 90%
91.8 to 114
Estimation Comments Trazodone Contramid® OAD (prototype 1)/Triticco®
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 1), Desyrel®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 105
Confidence Interval (2-Sided) 90%
93.9 to 117
Estimation Comments Trazodone Contramid® OAD (prototype 1)/Desyrel®
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 2), Triticco®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 95.3
Confidence Interval (2-Sided) 90%
85.5 to 106
Estimation Comments Trazodone Contramid® OAD (prototype 2)/Triticco®
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 2), Desyrel®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 97.7
Confidence Interval (2-Sided) 90%
87.7 to 109
Estimation Comments Trazodone Contramid® OAD (prototype 2)/Desyrel®
2.Primary Outcome
Title Bioequivalence Based on AUC(0-∞)
Hide Description

AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞).

Measured in nanogram x hours per milliliter (ng*h/mL).

Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.
Arm/Group Title Trazodone Contramid® OAD (Prototype 1) Trazodone Contramid® OAD (Prototype 2) Triticco® Desyrel®
Hide Arm/Group Description:
1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
Overall Number of Participants Analyzed 19 19 19 19
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
35122  (8655) 33373  (9299) 34165  (9105) 32485  (7621)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 1), Triticco®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 102
Confidence Interval (2-Sided) 90%
91.8 to 114
Estimation Comments Trazodone Contramid® OAD (prototype 1)/Triticco®
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 1), Desyrel®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 106
Confidence Interval (2-Sided) 90%
95.1 to 118
Estimation Comments Trazodone Contramid® OAD (prototype 1)/Desyrel®
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 2), Triticco®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 94.9
Confidence Interval (2-Sided) 90%
85.1 to 106
Estimation Comments Trazodone Contramid® OAD (prototype 2)/Triticco®
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 2), Desyrel®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 98.4
Confidence Interval (2-Sided) 90%
88.3 to 110
Estimation Comments Trazodone Contramid® OAD (prototype 2)/Desyrel®
3.Primary Outcome
Title Bioequivalence Based on Cmax
Hide Description Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.
Arm/Group Title Trazodone Contramid® OAD (Prototype 1) Trazodone Contramid® OAD (Prototype 2) Triticco® Desyrel®
Hide Arm/Group Description:
1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
Overall Number of Participants Analyzed 19 19 19 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
1260  (402) 1475  (489) 1688  (442) 2081  (492)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 1), Triticco®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 73.3
Confidence Interval (2-Sided) 90%
63.2 to 85
Estimation Comments Trazodone Contramid® OAD (prototype 1)/Triticco®
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 1), Desyrel®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 59.8
Confidence Interval (2-Sided) 90%
51.5 to 69.4
Estimation Comments Trazodone Contramid® OAD (prototype 1)/Desyrel®
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 2), Triticco®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 83
Confidence Interval (2-Sided) 90%
71.5 to 96.4
Estimation Comments Trazodone Contramid® OAD (prototype 2)/Triticco®
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Trazodone Contramid® OAD (Prototype 2), Desyrel®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.
Method of Estimation Estimation Parameter Mean ratio
Estimated Value 67.7
Confidence Interval (2-Sided) 90%
58.4 to 78.5
Estimation Comments Trazodone Contramid® OAD (prototype 2)/Desyrel®
4.Secondary Outcome
Title Apparent Terminal Half-life (t½.z)
Hide Description Apparent terminal half-life (t½.z) of trazodone in hours
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.
Arm/Group Title Trazodone Contramid® OAD (Prototype 1) Trazodone Contramid® OAD (Prototype 2) Triticco® Desyrel®
Hide Arm/Group Description:
1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
Overall Number of Participants Analyzed 19 19 19 19
Mean (Standard Deviation)
Unit of Measure: Hours
11.2  (3.92) 10.9  (3.55) 10.6  (3.25) 9.77  (2.49)
5.Secondary Outcome
Title Time to the Maximum Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.
Arm/Group Title Trazodone Contramid® OAD (Prototype 1) Trazodone Contramid® OAD (Prototype 2) Triticco® Desyrel®
Hide Arm/Group Description:
1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
Overall Number of Participants Analyzed 19 19 19 19
Median (Full Range)
Unit of Measure: Hours
12.0
(3.00 to 24.0)
6.00
(4.00 to 24.0)
13.0
(2.00 to 16.0)
8.50
(0.33 to 16.5)
6.Secondary Outcome
Title Apparent First Order Terminal Rate Constant [λz]
Hide Description Apparent First order terminal rate constant [λz] of trazodone in plasma expressed in 1/hours.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.
Arm/Group Title Trazodone Contramid® OAD (Prototype 1) Trazodone Contramid® OAD (Prototype 2) Triticco® Desyrel®
Hide Arm/Group Description:
1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
Overall Number of Participants Analyzed 19 19 19 19
Mean (Standard Deviation)
Unit of Measure: 1/hours
0.07  (0.02) 0.07  (0.02) 0.07  (0.02) 0.08  (0.02)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trazodone Contramid® OAD (Prototype 1) Trazodone Contramid® OAD (Prototype 2) Triticco® Desyrel®
Hide Arm/Group Description 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase. 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase. 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase. 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
All-Cause Mortality
Trazodone Contramid® OAD (Prototype 1) Trazodone Contramid® OAD (Prototype 2) Triticco® Desyrel®
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Trazodone Contramid® OAD (Prototype 1) Trazodone Contramid® OAD (Prototype 2) Triticco® Desyrel®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/20 (0.00%)      0/23 (0.00%)      0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Trazodone Contramid® OAD (Prototype 1) Trazodone Contramid® OAD (Prototype 2) Triticco® Desyrel®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/21 (33.33%)      9/20 (45.00%)      14/23 (60.87%)      14/21 (66.67%)    
Cardiac disorders         
Palpitations * 1  1/21 (4.76%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/21 (0.00%)  0
Eye disorders         
Eye pruritus * 1  0/21 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0 1/21 (4.76%)  1
Ocular hyperaemia * 1  0/21 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0 1/21 (4.76%)  1
Gastrointestinal disorders         
Abdominal discomfort * 1  0/21 (0.00%)  0 1/20 (5.00%)  1 0/23 (0.00%)  0 1/21 (4.76%)  2
Dry mouth * 1  0/21 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1 2/21 (9.52%)  2
Nausea * 1  1/21 (4.76%)  2 0/20 (0.00%)  0 1/23 (4.35%)  1 5/21 (23.81%)  5
Vomiting * 1  1/21 (4.76%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 1/21 (4.76%)  1
General disorders         
Fatigue * 1  1/21 (4.76%)  1 1/20 (5.00%)  1 4/23 (17.39%)  4 2/21 (9.52%)  2
Infections and infestations         
Gastroenteritis * 1  0/21 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0 1/21 (4.76%)  1
Nasopharyngitis * 1  2/21 (9.52%)  2 1/20 (5.00%)  1 0/23 (0.00%)  0 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Myalgia intercostal * 1  0/21 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders         
Dizziness * 1  4/21 (19.05%)  4 6/20 (30.00%)  6 6/23 (26.09%)  7 8/21 (38.10%)  9
Headache * 1  2/21 (9.52%)  3 1/20 (5.00%)  1 4/23 (17.39%)  5 6/21 (28.57%)  6
Syncope * 1  0/21 (0.00%)  0 1/20 (5.00%)  1 1/23 (4.35%)  1 0/21 (0.00%)  0
Tremor * 1  1/21 (4.76%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/21 (0.00%)  0
Hypotensive shock * 1 [1]  0/21 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Nasal congestion * 1  0/21 (0.00%)  0 1/20 (5.00%)  1 3/23 (13.04%)  3 1/21 (4.76%)  1
Oropharyngeal pain * 1  0/21 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0 1/21 (4.76%)  1
Skin and subcutaneous tissue disorders         
Hyperhidrosis * 1  1/21 (4.76%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/21 (0.00%)  0
Vascular disorders         
Hypotension * 1  0/21 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0 1/21 (4.76%)  1
Hypotension with convulsions * 1 [1]  0/21 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0 1/21 (4.76%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[1]
As reported
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.
The scientific results from this study are the property of the Sponsors, ie, Labopharm Inc., Canada and A.C.R.A.F. S.p.A., Italy. No data reported in the final integrated clinical trial report of this study will be used for publication in scientific journals and/or for presentation at scientific meetings without a previous agreed written consent between the Sponsors.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Regulatory Affairs
Organization: Labopharm Inc.
Phone: 1 450 686 1017
Layout table for additonal information
Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT01121913    
Other Study ID Numbers: 04ACL101
First Submitted: May 10, 2010
First Posted: May 12, 2010
Results First Submitted: June 22, 2010
Results First Posted: August 16, 2010
Last Update Posted: April 27, 2012