Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
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| ClinicalTrials.gov Identifier: NCT00672139 |
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Recruitment Status :
Completed
First Posted : May 6, 2008
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
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Sponsor:
Bausch Health Americas, Inc.
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Bausch Health Americas, Inc.
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Brief Summary:
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Opioid-Induced Constipation | Drug: Methylnaltrexone bromide | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 156 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation |
| Study Start Date : | July 2008 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | May 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Constipation
| Arm | Intervention/treatment |
|---|---|
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Experimental: Methylnaltrexone bromide
Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information. |
Drug: Methylnaltrexone bromide
Other Name: Relistor |
Primary Outcome Measures :
- Number of Laxations Per Subject Within 24 Hours of Dosing Per Week. [ Time Frame: 10 weeks ]This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
- Is receiving opioids on a regular schedule, not just as needed to control pain.
- Likely to continue to need treatment of OIC for the duration of participation in the study.
Exclusion Criteria:
- Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
- Currently using an opioid antagonist or partial antagonist.
- Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672139
Locations
Show 46 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Progenics Pharmaceuticals, Inc.
Investigators
| Study Director: | Enoch Bortey | Bausch Health Americas, Inc. |
| Responsible Party: | Bausch Health Americas, Inc. |
| ClinicalTrials.gov Identifier: | NCT00672139 |
| Other Study ID Numbers: |
3200K1-4001 B2541006 |
| First Posted: | May 6, 2008 Key Record Dates |
| Results First Posted: | March 7, 2018 |
| Last Update Posted: | March 7, 2018 |
| Last Verified: | February 2018 |
Keywords provided by Bausch Health Americas, Inc.:
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Opioid-Induced Constipation |
Additional relevant MeSH terms:
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Constipation Opioid-Induced Constipation Signs and Symptoms, Digestive Narcotic-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |
Bromides Methylnaltrexone Anticonvulsants Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |