NCT00259922 is a Phase 3 clinical trial of Alvimopan in Bowel Dysfunction, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

What drugs are being tested in NCT00259922?

Interventions in NCT00259922: Placebo, Alvimopan, Alviompan.

What condition does NCT00259922 study?

NCT00259922 studies Bowel Dysfunction, Constipation.

Is NCT00259922 still recruiting?

NCT00259922 is currently completed. Last updated 1 September 2015.

Last reviewed 2015-09-01 · How we verify

NCT00259922

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain

Completed Phase 3 Last updated 1 September 2015

What this trial tests

Phase 3 trial testing Placebo in Bowel Dysfunction in 485 participants. Completed.

Timeline

1 August 2005

Primary endpoint
1 June 2006

Quick facts

Lead sponsor	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	485
Start date	1 August 2005
Primary completion	1 June 2006
Sites	187 locations across United States, Australia, Canada, France, Hungary, Netherlands, New Zealand, Norway

Drugs / interventions tested

Placebo
Alvimopan (ALVIMOPAN) — full drug profile →
Alviompan — full drug profile →

Conditions studied

Bowel Dysfunction — all drugs for Bowel Dysfunction →
Constipation — all drugs for Constipation →

Sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →

Who can join

18 and older, any sex, with Bowel Dysfunction or Constipation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To compare alvimopan with placebo for efficacy in the treatment of OBD

Sponsor's own description

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Alvimopan

Trials testing the same drug.

NCT04405037 — Alvimopan as a Rescue Treatment of Postoperative Ileus · Phase 4 · completed
NCT03216525 — Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol · Phase 3 · recruiting
NCT03352414 — Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC · Phase 2 · terminated
NCT03068975 — Alvimopan Use in Polytraumatized Patients · Phase 4 · terminated
NCT02789111 — Trial of Alvimopan in Major Spine Surgery · Phase 4 · completed

Other recruiting trials for Bowel Dysfunction

Currently open trials in the same condition.

NCT06587841 — Noninvasive Spinal Cord Stimulation for Early SCI · NA · recruiting
NCT05380856 — Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction · NA · recruiting
NCT06311110 — Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD · recruiting
NCT06288464 — Enteral Feeding of Fibre to Improve Microbiota · NA · recruiting

Other Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials

Trials by the same sponsor.

NCT02276482 — Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012) · Phase 3 · completed
NCT02387372 — Plasma Pharmacokinetics (PK) & Lung Penetration of Ceftolozane/Tazobactam in Participants With Pneumonia (MK-7625A-007) · Phase 1 · completed
NCT02341599 — Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compare · Phase 1 · completed
NCT02266706 — Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Pr · Phase 1 · completed
NCT02070757 — Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008) · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00259922 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Last refreshed: 1 September 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00259922.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing