NCT00388258 is a Phase 3 clinical trial of Alvimopan in Ileus, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

What drugs are being tested in NCT00388258?

Interventions in NCT00388258: Alvimopan.

Is NCT00388258 still recruiting?

NCT00388258 is currently completed. Last updated 22 August 2017.

Last reviewed 2017-08-22 · How we verify

NCT00388258

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

Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus

Completed Phase 3 Last updated 22 August 2017

What this trial tests

Phase 3 trial testing Alvimopan in Ileus in 451 participants. Completed in 1 December 2002.

Timeline

1 March 2001

Primary endpoint
1 December 2002

1 December 2002

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	double
Primary purpose	treatment
Enrollment	451
Start date	1 March 2001
Primary completion	1 December 2002
Estimated completion	1 December 2002
Sites	1 location across United States

Drugs / interventions tested

Alvimopan (ALVIMOPAN) — full drug profile →

Conditions studied

Ileus — all drugs for Ileus →

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 Ileus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery (bowel resection or abdominal hysterectomy).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Alvimopan for the management of postoperative ileus after bowel resection: characterization of clinical benefit by pooled responder analysis.
Ludwig K, Viscusi ER, Wolff BG, Delaney CP, et al · · 2010 · cited 29× · PMID 20526599 · DOI 10.1007/s00268-010-0635-9

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 Ileus

Currently open trials in the same condition.

NCT07432542 — Pelvic Floor Peritoneal Closure to Prevent Postoperative Ileus in Mid-Low Rectal Cancer Surgery · NA · active not recruiting
NCT06815822 — Prevention of Postoperative Hernias in Emergency Surgery · 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 NCT00388258 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 22 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/NCT00388258.

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