Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
This study has been withdrawn prior to enrollment.
(Withdrawn [This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.)
Sponsor:
Salix Pharmaceuticals
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00858754
First received: March 9, 2009
Last updated: July 22, 2011
Last verified: July 2011
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Purpose
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid-Induced Constipation |
Drug: methylnaltrexone Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Salix Pharmaceuticals:
Primary Outcome Measures:
- Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments. [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 340 |
| Study Start Date: | March 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1 Active Drug
Methylnaltrexone
|
Drug: methylnaltrexone
Other Name: MOA-728
|
|
Placebo Comparator: Group 2 Non-Active Drug
Placebo
|
Drug: placebo
Other Name: Inactive
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858754
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Laguna Hills, California, United States, 92637 | |
| Pfizer Investigational Site | |
| Lancaster, California, United States, 93534 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Flat Rock, North Carolina, United States, 28731 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Madison, Wisconsin, United States, 53792 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| France | |
| Pfizer Investigational Site | |
| Unknown, Tarbes, France, 65000 | |
| Pfizer Investigational Site | |
| Villejuif Cedex, France, 94804 | |
| Spain | |
| Pfizer Investigational Site | |
| El Palmar, Murcia/Spain, Spain, 30120 | |
Sponsors and Collaborators
Salix Pharmaceuticals
Progenics Pharmaceuticals, Inc.
Investigators
| Study Director: | Jeff Cohn | Salix Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jeff Cohn, Salix Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00858754 History of Changes |
| Other Study ID Numbers: | 3200K1-4006 |
| Study First Received: | March 9, 2009 |
| Last Updated: | July 22, 2011 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Argentina: Human Research Bioethics Committee Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee Canada: Health Canada Egypt: Institutional Review Board Egypt: Ministry of Health and Population European Union: European Medicines Agency Malaysia: Ministry of Health Philippines: Department of Health Philippines: Bureau of Food and Drugs Saudi Arabia: Ministry of Health Singapore: Clinical Trials & Epidemiology Research Unit (CTERU) Singapore: Domain Specific Review Boards Singapore: Health Sciences Authority Spain: Ministry of Health Spain: Ministry of Health and Consumption Spain: Spanish Agency of Medicines United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health United Arab Emirates: General Authority for Health Services for Abu Dhabi United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Salix Pharmaceuticals:
|
opioid induced constipation Cancer patients methylnaltrexone |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms Methylnaltrexone Naltrexone Analgesics, Opioid Narcotic Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 23, 2013