NCT01367574

Brief Summary

This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2002

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
8.1 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

1.1 years

First QC Date

May 27, 2011

Last Update Submit

November 26, 2019

Conditions

Bowel Dysfunction

Keywords

Opioid-induced bowel dysfunction

Outcome Measures

Primary Outcomes (1)

  • Number of subjects who have a bowel movement within four hours of dosing

    To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.

    Up to 4 weeks

Secondary Outcomes (1)

  • Number of subject with Adverse Events

    Up to 4 weeks

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: SC MNTX

Arm 2

EXPERIMENTAL
Drug: SC MNTX

Arm 3

EXPERIMENTAL
Drug: SC MNTX

Interventions

SC MNTXDRUG

Dose 1

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care
  • Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen
  • Must have constipation
  • Must be 18 yrs or older

You may not qualify if:

  • Concurrent use of medications other than opioids which might interfere with gastrointestinal motility
  • Patients who received any experimental drug in the last 30 days
  • Patients with active peritoneal cancer (ovarian, etc.)
  • Patients with active diverticulitis or diverticulosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Conditions

Intestinal DiseasesOpioid-Induced Constipation

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesConstipationSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Tage Ramakrishna, MD

    Progenics Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 7, 2011

Study Start

April 1, 2002

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)