A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients
NCT00401362
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1. Advanced medical illness with a life expectancy of 1 to 6 months
2. No clinically significant laxation within 48 hours prior to the first dose of study drug
3. On stable opioid and laxative regimen for a least 3 days prior to treatment
4. Age greater than 18years
5. Females of child-bearing age must have a negative pregnancy test.
1. Females who are pregnant or nursing.
2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for
treatment of OIC
3. Any disease process suggestive of gastrointestinal obstruction
4. Fecal ostomy.
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Descriptive Information | ||||
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Brief Title ICMJE | A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients | |||
Official Title ICMJE | A Double-Blind Placebo-Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Chronic Opioid Therapy in Patients With Advanced Medical Illness | |||
Brief Summary | To test the effectiveness of MNTX in advanced illness subjects. | |||
Detailed Description | To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Advanced Illness Patients With Opioid Induced Constipation | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 154 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | February 2005 | |||
Actual Primary Completion Date | February 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00401362 | |||
Other Study ID Numbers ICMJE | MNTX 301 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc. | |||
Study Sponsor ICMJE | Bausch Health Americas, Inc. | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Bausch Health Americas, Inc. | |||
Verification Date | November 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |