NCT00241722 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 NCT00241722?

Interventions in NCT00241722: Alvimopan, Placebo.

What condition does NCT00241722 study?

NCT00241722 studies Bowel Dysfunction, Constipation.

Is NCT00241722 still recruiting?

NCT00241722 is currently completed. Last updated 30 August 2017.

Last reviewed 2017-08-30 · How we verify

NCT00241722

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

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

Completed Phase 3 Last updated 30 August 2017

What this trial tests

Phase 3 trial testing Alvimopan in Bowel Dysfunction in 805 participants. Completed in 1 February 2007.

Timeline

1 August 2005

Primary endpoint
1 February 2007

1 February 2007

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	805
Start date	1 August 2005
Primary completion	1 February 2007
Estimated completion	1 February 2007
Sites	227 locations across Denmark, Hong Kong, Finland, Netherlands, New Zealand, Austria, Sweden, Ireland

Drugs / interventions tested

Alvimopan (ALVIMOPAN) — full drug profile →
Placebo

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.

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) 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.

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 NCT00241722 (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: 30 August 2017

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/NCT00241722.

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