Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid
September 1, 2015 updated by: Cubist Pharmaceuticals LLC
Clinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-controlled Double-blind Study in Cancer Patients-
This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group.
Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Have cancer.
- Taking opioid therapy for continued intractable pain.
- Experiencing less bowel movement frequency compared to that before the opioid treatment.
- Must meet the protocol-definition of opioid-induced constipation.
Exclusion criteria:
- Gastrointestinal or pelvic disorders known to affect gastrointestinal functions or induce bowel transit disorder and ileus.
- Subjects, who in the investigator's opinion, have gastrointestinal dysfunction predominantly due to causes other than the use of opioids.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
|
|
Experimental: Alvimopan 0.25 mg/yday
|
0.25 mg/day
Other Names:
|
|
Experimental: Alviompan 0.5 mg/day
|
|
|
Experimental: Alvimopan 1 mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Change from baseline during the 1-week Pre-Treatment Period in average weekly bowel movement with no rescue laxative use in the previous 24 hours Frequency during the 3-week Treatment Period
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Proportion of responders for OBD global improvement Changes in weekly subjective bowel movement symptoms Changes in weekly constipation symptoms questionnaire
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
May 26, 2006
First Submitted That Met QC Criteria
May 26, 2006
First Posted (Estimate)
May 29, 2006
Study Record Updates
Last Update Posted (Estimate)
September 2, 2015
Last Update Submitted That Met QC Criteria
September 1, 2015
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABD102965
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.