Methylnaltrexone for Opioid-induced Constipation in Cancer Patients

NCT01004393 | Completed Phase 2 Results DMC

• 1 other identifier: VCC 0911
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms; Constipation; Opioid-Related Disorders

Keywords

Methylnaltrexone; Constipation; Narcotic Antagonists; Analgesics, Opioid; Neoplasms

Outcome Measures

Primary Outcomes (1)

• Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone

  4 hours after the dose of subcutaneous methylnaltrexone

Secondary Outcomes (7)

• Laxation After Administration of Subcutaneous Methylnaltrexone

  24 and 48 hours after the dose of subcutaneous methylnaltrexone

• Time to Laxation After Administration of Subcutaneous Methylnaltrexone

  48 hours after the dose of subcutaneous methylnaltrexone

• Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone

  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

  48 hours after the dose of subcutaneous methylnaltrexone

• Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone

  48 hours after the dose of subcutaneous methylnaltrexone

Study Arms (1)

Methylnaltrexone bromide

EXPERIMENTAL

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.

Drug: Methylnaltrexone bromide

Interventions

Methylnaltrexone bromide DRUG

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

Also known as: Relistor

Methylnaltrexone bromide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed neoplasm
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• Mori 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 DERIVED

MeSH Terms

Conditions

Neoplasms; Constipation; Opioid-Related Disorders

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Masanori Mori, MD
• Organization: Seirei Hamamatsu General Hospital

Masanori.Mori@sis.seirei.or.jp

81-53-474-2222

Study Officials

• Steven Ades, MD

  Fletcher Allen Health Care / University of Vermont College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 29, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 2, 2016
• Results First Posted: February 2, 2016

Record last verified: 2015-12

Locations

US (1)