Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
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Purpose
The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving opioid-induced constipation in cancer patients at various stages of disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms Constipation Opioid-Related Disorders |
Drug: Methylnaltrexone bromide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Phase II Trial of Subcutaneous Methylnaltrexone in the Treatment of Severe Opioid-induced Constipation in Cancer Patients |
- Rescue-free laxation after administration of subcutaneous methylnaltrexone [ Time Frame: 4 hours after the dose of subcutaneous methylnaltrexone ] [ Designated as safety issue: No ]
- Rescue-free laxation after administration of subcutaneous methylnaltrexone [ Time Frame: 24 hours after the dose of subcutaneous methylnaltrexone ] [ Designated as safety issue: No ]
- Laxation with or without rescue laxatives after administration of subcutaneous methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ] [ Designated as safety issue: No ]
- Time to laxation after administration of subcutaneous methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ] [ Designated as safety issue: No ]
- Overall pain scores after administration of subcutaneous methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ] [ Designated as safety issue: Yes ]
- Symptoms of opioid withdrawal after administration of subcutaneous methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ] [ Designated as safety issue: Yes ]
- Bowel movement assessment (frequency, consistency and difficulty) after administration of subcutaneous methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ] [ Designated as safety issue: No ]
- Constipation assessment (severity and distress) after administration of subcutaneous methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ] [ Designated as safety issue: Yes ]
- Patient satisfaction with the study medication after administration of subcutaneous methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 17 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Methylnaltrexone |
Drug: Methylnaltrexone bromide
Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
Other Name: Relistor
|
Detailed Description:
Pain is one of the most common and important symptoms of cancer, often requiring opioid analgesics for control. However constipation is one of the most frequent and debilitating side effects of opioids, occurring in 40%-70% of patients being treated for chronic pain. Although laxatives are commonly used to manage opioid-induced constipation, these agents are not always effective or satisfactory. Methylnaltrexone bromide is a peripherally acting antagonist of the mu-opioid receptor. As a quaternary amine, the ability of methylnaltrexone to cross the blood-brain barrier is limited. This allows methylnaltrexone to function as a peripherally-acting antagonist in the gastrointestinal tract without impacting opioid-mediated analgesic effects in the central nervous system. The efficacy and safety of methylnaltrexone in treating opioid-induced constipation in patients with advanced disease receiving palliative care has been demonstrated. However the efficacy of this agent has not been evaluated in more active patients who are earlier in their disease course. The present study will evaluate the efficacy and safety of methylnaltrexone for the relief of severe opioid-induced constipation in this population and will attempt to identify factors predictive of methylnaltrexone response.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed neoplasm
- 18 years of age or older
- Have received opioids for analgesia for at least 2 weeks and been on a stable regimen of opioids and laxatives for 3 or more days before study entry
- Fewer than three laxations during the preceding week and no laxation within 24 hours before study entry, or no laxation within 48 hours before study entry
- Life expectancy of at least 6 months
- WHO Performance Status 0-3
- Women of childbearing potential must have a negative pregnancy test
- Breastfeeding should be discontinued prior to study entry
- Ability to understand and the willingness to sign a written informed consent document.
- Laboratory values within a week of study entry:
Absolute neutrophil count > 1,500/microliter Hemoglobin > 7 g/dL Platelet count > 100,000/microliter Calculated calcium < 10.5 mg/dL Calculated creatinine clearance > 30 mg.min Alanine aminotransferase < 3 x upper limit of normal (ULN) Aspartate aminotransferase < 3 x ULN Alkaline phosphatase < 2.5 x ULN Bilirubin < 1.5 x ULN
Exclusion Criteria:
- Constipation not primarily caused by opioids, such as mechanical gastrointestinal obstruction or ongoing vinca alkaloid administration
- Indwelling peritoneal catheter
- Clinically active diverticular disease
- Fecal impaction
- Acute surgical abdomen
- Fecal ostomy
- Peritoneal carcinomatosis
- Known hypersensitivity to methylnaltrexone, naltrexone, or naloxone
- Administration of any investigational drug or experimental product within the previous 30 days
- Initiation of a new bowel regimen or prokinetic agents within a week of study entry
Contacts and Locations| Contact: Steven M Grunberg, MD | 802-847-8400 | Steven.Grunberg@uvm.edu |
| Contact: Masanori Mori, MD | 802-847-8400 | Masanori.Mori@vtmednet.org |
| United States, Vermont | |
| Fletcher Allen Health Care | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Steven M Grunberg, MD 802-847-8400 Steven.Grunberg@uvm.edu | |
| Contact: Masanori Mori, MD 802-847-8400 Masanori.Mori@vtmednet.org | |
| Principal Investigator: Steven M Grunberg, MD | |
| Sub-Investigator: Masanori Mori, MD | |
| Principal Investigator: | Steven M Grunberg, MD | Fletcher Allen Health Care / University of Vermont College of Medicine |
More Information
No publications provided
| Responsible Party: | Steven Grunberg, Professor of Medicine, University of Vermont |
| ClinicalTrials.gov Identifier: | NCT01004393 History of Changes |
| Other Study ID Numbers: | VCC 0911, VCC 0911 |
| Study First Received: | October 28, 2009 |
| Last Updated: | March 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Vermont:
|
Methylnaltrexone Constipation Narcotic Antagonists Analgesics, Opioid Neoplasms |
Additional relevant MeSH terms:
|
Narcotic Antagonists Neoplasms Constipation Opioid-Related Disorders Signs and Symptoms, Digestive Signs and Symptoms Substance-Related Disorders Mental Disorders Bromides Methylnaltrexone Naltrexone |
Analgesics, Opioid Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 17, 2013