NCT00331045 is a Phase 2 clinical trial of alvimopan in Cancer, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

What drugs are being tested in NCT00331045?

Interventions in NCT00331045: alvimopan, Placebo, Alvimopan 0.5 mg/day, Alvimopan 1 mg/day.

What condition does NCT00331045 study?

NCT00331045 studies Cancer, Constipation.

Is NCT00331045 still recruiting?

NCT00331045 is currently terminated. Last updated 1 September 2015.

Last reviewed 2015-09-01 · How we verify

NCT00331045

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

Clinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-controlled Double-blind Study in Cancer Patients-

Terminated Phase 2 Last updated 1 September 2015

What this trial tests

Phase 2 trial testing alvimopan in Cancer in 21 participants. Terminated before completion.

Timeline

1 April 2006

Primary endpoint
1 October 2006

1 December 2006

Quick facts

Lead sponsor	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	21
Start date	1 April 2006
Primary completion	1 October 2006
Estimated completion	1 December 2006

Drugs / interventions tested

alvimopan (ALVIMOPAN) — full drug profile →
Placebo
Alvimopan 0.5 mg/day — full drug profile →
Alvimopan 1 mg/day — full drug profile →

Conditions studied

Cancer — all drugs for Cancer →
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

20 and older, any sex, with Cancer 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.

Change from baseline during the 1-week Pre-Treatment Period in average weekly bowel movement with no rescue laxative use in the previous 24 hours Frequency during the 3-week Treatment Period

Sponsor's own description

This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.

Publications & conference data

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

Mu-opioid antagonists for opioid-induced bowel dysfunction in people with cancer and people receiving palliative care.
Candy B, Jones L, Vickerstaff V, Larkin PJ, et al · · 2018 · cited 18× · PMID 29869799 · DOI 10.1002/14651858.cd006332.pub3

Verify or expand the search:

Other trials of alvimopan

Trials testing the same drug.

NCT00101998 — Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication · Phase 2 · completed

Other recruiting trials for Cancer

Currently open trials in the same condition.

NCT07390045 — Exercise and Cognitive Rehabilitation Interventions for Older Cancer Survivors · NA · recruiting
NCT07528547 — Hypersight and Ethos In Pediatric Radiotherapy · NA · recruiting
NCT07481890 — Feasibility and Efficacy of the EMDR Toolbox Method in Cancer Patients. · NA · recruiting
NCT07402057 — Implementation and Evaluation of a Program Aimed at Facilitating Palliative Care Conversations · NA · recruiting
NCT07305740 — On-Trac: An Online Intervention for Cancer Survivors Managing Anxiety · 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 NCT00331045 (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: 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/NCT00331045.

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