Clinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-Controlled Double-Blind Study in Cancer Patients-
Phase 2
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Cancer, Constipation
Both
Cancer, Constipation
Trial Information
Clinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-Controlled Double-Blind Study in Cancer Patients-
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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
Principal Investigator
GSK Clinical Trials, MD
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
ABD102965
NCT ID:
NCT00331045
Start Date:
April 2006
Completion Date:
Related Keywords:
- Cancer
- Constipation
- Opioids
- cancer
- constipation
- Constipation
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