A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain
18 Years
90 Years
Both
Opioid-Induced Constipation
Trial Information
A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain
Inclusion Criteria:
- Is a man or woman aged 18 years or older.
- Has a body weight >= 38 kg.
- Has cancer (active or in remission), and has cancer-related pain (ie, pain due to
cancer or treatment of cancer).
- Has a life expectancy of >= 6 months.
- Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology
Group (ECOG) scale.
- Is taking opioids for cancer-related pain, and not just as-needed doses.
- Has a diagnosis of OIC as determined by the investigator.
- Is willing to follow the protocol instructions on laxative use during the study.
Exclusion Criteria:
- Has a history of chronic constipation before starting opioids.
- Has renal disease receiving dialysis.
- Has an ostomy for stools.
- Is a pregnant or breastfeeding woman.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.
Outcome Time Frame:
1 Day
Safety Issue:
Yes
Principal Investigator
Jeff Cohn
Investigator Role:
Study Director
Investigator Affiliation:
Salix Pharmaceuticals
Authority:
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study ID:
3200K1-4006
NCT ID:
NCT00858754
Start Date:
March 2009
Completion Date:
August 2009
Related Keywords:
- Opioid-Induced Constipation
- opioid induced constipation
- Cancer patients
- methylnaltrexone
- Constipation
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Milwaukee, Wisconsin 53215 |
