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Trial record 59 of 10795 for:    Placebo AND once

Evaluation of the Efficacy and Safety of ADL5945 Once Daily for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain

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ClinicalTrials.gov Identifier: NCT01275755
Recruitment Status : Completed
First Posted : January 12, 2011
Results First Posted : June 8, 2015
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Constipation
Interventions Drug: Placebo
Drug: ADL5945 0.25 mg
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo ADL5945 0.25 mg
Hide Arm/Group Description Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week). During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
Period Title: Run-in Placebo Period
Started 41 40
Completed 41 40
Not Completed 0 0
Period Title: Double-blind Treatment Period
Started 41 40
Received at Least 1 Dose of Study Drug 41 40
Completed 39 37
Not Completed 2 3
Reason Not Completed
Adverse Event             0             2
Lost to Follow-up             1             1
Withdrawal by Subject             1             0
Period Title: Run-out Placebo Period
Started 39 37
Completed 38 37
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Placebo ADL5945 0.25mg Total
Hide Arm/Group Description Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week). During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Total of all reporting groups
Overall Number of Baseline Participants 41 40 81
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
LTE18
0
   0.0%
0
   0.0%
0
   0.0%
BTWN
37
  90.2%
35
  87.5%
72
  88.9%
GTE65
4
   9.8%
5
  12.5%
9
  11.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
Female
28
  68.3%
28
  70.0%
56
  69.1%
Male
13
  31.7%
12
  30.0%
25
  30.9%
1.Primary Outcome
Title Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment
Hide Description An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.
Time Frame Baseline, Weeks 1 through 4 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized to study treatment and had at least 1 evaluable SBM post-dose measurement during the Double-blind Treatment Period. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.
Arm/Group Title Placebo ADL5945 0.25 mg
Hide Arm/Group Description:
Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
Overall Number of Participants Analyzed 41 40
Mean (Standard Error)
Unit of Measure: Number of SBMs/week
1.40  (0.26) 2.58  (0.34)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo ADL5945 0.25 mg
Hide Arm/Group Description Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week). During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
All-Cause Mortality
Placebo ADL5945 0.25 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo ADL5945 0.25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      1/40 (2.50%)    
Cardiac disorders     
Cardiac Arrest  [1]  0/41 (0.00%)  0 1/40 (2.50%)  1
Indicates events were collected by systematic assessment
[1]
This Serious Adverse Event occurred 35 days following last dose of double-blind study medication. The participant died as a result of this SAE
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Placebo ADL5945 0.25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/41 (26.83%)      10/40 (25.00%)    
Gastrointestinal disorders     
Abdominal Pain   1/41 (2.44%)  1 2/40 (5.00%)  2
Abdominal Pain Upper   3/41 (7.32%)  3 2/40 (5.00%)  2
Diarrhea   0/41 (0.00%)  0 2/40 (5.00%)  2
Nausea   2/41 (4.88%)  2 0/40 (0.00%)  0
Vomiting   1/41 (2.44%)  1 1/40 (2.50%)  1
Nervous system disorders     
Headache   2/41 (4.88%)  2 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchitis   1/41 (2.44%)  1 2/40 (5.00%)  2
Upper respiratory tract infection   1/41 (2.44%)  1 1/40 (2.50%)  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
Name/Title: Vice President, Clinical Research
Organization: Cubist Pharmaceuticals
Phone: (781) 860-8660
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01275755     History of Changes
Other Study ID Numbers: 2402-002
45CL243 ( Other Identifier: Cubist Study Number )
First Submitted: January 11, 2011
First Posted: January 12, 2011
Results First Submitted: April 21, 2015
Results First Posted: June 8, 2015
Last Update Posted: November 15, 2018