Status:
TERMINATED
Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Cancer
Constipation
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00331045
Start Date
April 1 2006
End Date
December 1 2006
Last Update
September 2 2015
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