Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01367548
First received: May 27, 2011
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.


Condition Intervention Phase
Postoperative Ileus
Drug: IV Methylnaltrexone (MNTX)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II Double-Blind Randomized Parallel Group Study of Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Time to tolerance of liquids [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.


Secondary Outcome Measures:
  • Time to first bowel movement [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.

  • Time to tolerance of solid foods [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.

  • Time to first micturition post foley catheter removal [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.

  • Time to hospital discharge [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the activity of parenterally administered MNTX compared with placebo in shortening the duration of or preventing post-operative ileus in patients who have undergone segmental colectomies.


Enrollment: 65
Study Start Date: July 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: IV Methylnaltrexone (MNTX)
Placebo Comparator: Arm 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females, 18 yrs or older
  2. Patients who have undergone a segmental colectomy
  3. Must be receiving opioids via IV.

Exclusion Criteria:

  1. Patients who received any experimental drug in the last 30 days
  2. Patients receiving spinal medication for post-operative pain relief
  3. Patients who have undergone operations for complications related to inflammatory bowel disease
  4. Patients with recent history of abdominal radiation therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367548

Locations
United States, New York
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367548     History of Changes
Other Study ID Numbers: MNTX 203
Study First Received: May 27, 2011
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Methylnaltrexone
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014