Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
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ClinicalTrials.gov Identifier: NCT01004393 |
Recruitment Status :
Completed
First Posted : October 29, 2009
Results First Posted : February 2, 2016
Last Update Posted : February 2, 2016
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Condition or disease | Intervention/treatment | Phase |
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Neoplasms Constipation Opioid-Related Disorders | Drug: Methylnaltrexone bromide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
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Experimental: Methylnaltrexone bromide
A single dose of methylnaltrexone will be administered subcutaneously to eligible subjects based on weight at the study entry. Since we will include subjects at all stages of cancer management, administering this study drug is considered experimental. We will use the dose approved by FDA, i.e., 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.
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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 |
- Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone [ Time Frame: 4 hours after the dose of subcutaneous methylnaltrexone ]
- Laxation After Administration of Subcutaneous Methylnaltrexone [ Time Frame: 24 and 48 hours after the dose of subcutaneous methylnaltrexone ]
- Time to Laxation After Administration of Subcutaneous Methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ]
- Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ]
- Symptoms of Opioid Withdrawal (Modified Himmelsbach Withdrawal Scales (Ranging 7-28 in Total; 1=None - 4=Severe for 7 Items)) After Administration of Subcutaneous Methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ]
- Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ]
- Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ]
- Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone [ Time Frame: 48 hours after the dose of subcutaneous methylnaltrexone ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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 laxation 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
- World Health Organization 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

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): NCT01004393
United States, Vermont | |
Fletcher Allen Health Care | |
Burlington, Vermont, United States, 05401 |
Principal Investigator: | Steven Ades, MD | Fletcher Allen Health Care / University of Vermont College of Medicine |
Responsible Party: | Steven Ades, Associate Professor, University of Vermont |
ClinicalTrials.gov Identifier: | NCT01004393 |
Other Study ID Numbers: |
VCC 0911 VCC 0911 ( Other Identifier: Vermont Cancer Center ) |
First Posted: | October 29, 2009 Key Record Dates |
Results First Posted: | February 2, 2016 |
Last Update Posted: | February 2, 2016 |
Last Verified: | December 2015 |
Methylnaltrexone Constipation Narcotic Antagonists Analgesics, Opioid Neoplasms |
Constipation Opioid-Related Disorders Signs and Symptoms, Digestive Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Bromides |
Methylnaltrexone Anticonvulsants Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |