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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367548
First Posted: June 7, 2011
Last Update Posted: July 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Valeant Pharmaceuticals International, Inc.
May 27, 2011
June 7, 2011
July 19, 2011
July 2003
December 2004   (Final data collection date for primary outcome measure)
Time to tolerance of liquids [ Time Frame: 7 days ]
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.
Same as current
Complete list of historical versions of study NCT01367548 on ClinicalTrials.gov Archive Site
  • Time to first bowel movement [ Time Frame: 7 days ]
    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 ]
    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 ]
    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 ]
    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.
Same as current
Not Provided
Not Provided
 
Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
A Phase II Double-Blind Randomized Parallel Group Study of Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Postoperative Ileus
  • Drug: IV Methylnaltrexone (MNTX)
  • Drug: Placebo
  • Experimental: Arm 1
    Intervention: Drug: IV Methylnaltrexone (MNTX)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
December 2004
December 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01367548
MNTX 203
No
Not Provided
Not Provided
Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
Valeant Pharmaceuticals International, Inc.
Not Provided
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
Valeant Pharmaceuticals International, Inc.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP