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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals Holdings LLC ( Cubist Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01207427
First received: September 21, 2010
Last updated: April 21, 2015
Last verified: April 2015
Results First Received: April 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Opioid Induced Constipation
Interventions: Drug: Placebo
Drug: ADL5945 0.1 mg
Drug: ADL5945 0.25 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ADL5945 0.1 mg During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-milligrams (mg) ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
ADL5945 0.25 mg During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
Placebo Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).

Participant Flow for 3 periods

Period 1:   Run-in Placebo Period
    ADL5945 0.1 mg     ADL5945 0.25 mg     Placebo  
STARTED     43     45     43  
COMPLETED     43     45     43  
NOT COMPLETED     0     0     0  

Period 2:   Double-blind Treatment Period
    ADL5945 0.1 mg     ADL5945 0.25 mg     Placebo  
STARTED     43     45     43  
Received at Least 1 Dose of Study Drug     43     45     43  
COMPLETED     40     43     41  
NOT COMPLETED     3     2     2  
Adverse Event                 0                 1                 0  
Lost to Follow-up                 0                 0                 1  
Protocol Violation                 2                 1                 1  
Withdrawal by Subject                 1                 0                 0  

Period 3:   Run-out Placebo Period
    ADL5945 0.1 mg     ADL5945 0.25 mg     Placebo  
STARTED     40     43     41  
COMPLETED     40     43     41  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study drug

Reporting Groups
  Description
ADL5945 0.1 mg During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1 mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
ADL5945 0.25 mg During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
Placebo Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
Total Total of all reporting groups

Baseline Measures
    ADL5945 0.1 mg     ADL5945 0.25 mg     Placebo     Total  
Number of Participants  
[units: participants]
  43     45     43     131  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     40     44     40     124  
>=65 years     3     1     3     7  
Gender  
[units: participants]
       
Female     20     20     23     63  
Male     23     25     20     68  



  Outcome Measures

1.  Primary:   Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment   [ Time Frame: Baseline, Weeks 1 through 4 of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Clinical Research
Organization: Cubist Pharmaceuticals
phone: (781) 860-8660


No publications provided


Responsible Party: Cubist Pharmaceuticals Holdings LLC ( Cubist Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01207427     History of Changes
Other Study ID Numbers: 45CL242
Study First Received: September 21, 2010
Results First Received: April 21, 2015
Last Updated: April 21, 2015
Health Authority: United States: Food and Drug Administration