Clinical trial · Interventional
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
Phase II Trial of Subcutaneous Methylnaltrexone in the Treatment of Severe Opioid-induced Constipation in Cancer Patients
NCT01004393CI-TRIAL-00020748completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Constipation | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Opioid-Related Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylnaltrexone bromide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Methylnaltrexone bromide
- description
- 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.
- interventionNames
- Drug: Methylnaltrexone bromide
Primary outcomes (1)
- measure
- Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone
- timeFrame
- 4 hours after the dose of subcutaneous methylnaltrexone
Secondary outcomes (7)
- measure
- Laxation After Administration of Subcutaneous Methylnaltrexone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMori M, Ji Y, Kumar S, Ashikaga T, Ades S. Phase II trial of subcutaneous methylnaltrexone in the treatment of severe opioid-induced constipation (OIC) in cancer patients: an exploratory study. Int J Clin Oncol. 2017 Apr;22(2):397-404. doi: 10.1007/s10147-016-1041-6. Epub 2016 Sep 15. PMID 27628064