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NCT00241722 · ClinicalTrials.gov registry record · Phase 3

Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

A Phase 3 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

Completed
Registry status
Phase 3
Development phase
805
Enrollment target

NCT00241722 is a Phase 3 study that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 805 participants.

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The verdict

NCT00241722, a Phase 3 study, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

COMPLETED
Registry status
Phase 3
Development phase
805 participants
Enrollment target

Study Summary

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.

Interventions

  • DRUG Placebo
  • DRUG Alvimopan

Trial Details

FieldValue
Enrollment Target 805 participants
Start Date 2005-08-01
Est. Completion 2007-02-01
Phase Phase 3

What the Registry Record Tells You About NCT00241722

The ClinicalTrials.gov registry entry for NCT00241722 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 805 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00241722 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00241722 about?

NCT00241722 is a clinical study titled "Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain". Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerabilit...

What is the current status of trial NCT00241722?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 805 participants. The study started on 2005-08-01. Estimated completion is 2007-02-01.

What interventions are being tested in trial NCT00241722?

The interventions under investigation include: Placebo (DRUG), Alvimopan (DRUG).

Who is sponsoring clinical trial NCT00241722?

This trial is sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.