Phase 2
N=12
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
Neoplasms · Constipation · Opioid-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01004393 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone — 33 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Methylnaltrexone bromide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone |
33 | — |
| SECONDARY Laxation After Administration of Subcutaneous Methylnaltrexone |
42; 83 | — |
| SECONDARY Time to Laxation After Administration of Subcutaneous Methylnaltrexone |
3.3; 16; 20 | — |
| SECONDARY Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone |
2.9; 2.4; 2.3 | — |
| SECONDARY 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 |
8.8; 9.2; 8.8 | — |
| SECONDARY Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone |
33; 42; 73; 8; 8; 9 | — |
| SECONDARY Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone |
42; 50; 27; 25; 25; 0 | — |
| SECONDARY Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone |
33; 58; 64 | 0.161 |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01004393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.