NCT01367548

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

1.4 years

First QC Date

May 27, 2011

Last Update Submit

November 26, 2019

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

  • Time to tolerance of liquids

    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.

    7 days

Secondary Outcomes (4)

  • Time to first bowel movement

    7 days

  • Time to tolerance of solid foods

    7 days

  • Time to first micturition post foley catheter removal

    7 days

  • Time to hospital discharge

    7 days

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: IV Methylnaltrexone (MNTX)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

IV Methylnaltrexone (MNTX)DRUG
Arm 1
PlaceboDRUG
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who received any experimental drug in the last 30 days
  • Patients receiving spinal medication for post-operative pain relief
  • Patients who have undergone operations for complications related to inflammatory bowel disease
  • Patients with recent history of abdominal radiation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Interventions

methylnaltrexone

Study Officials

  • Tage Ramakrishna, MD

    Progenics Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 7, 2011

Study Start

July 1, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)