Who is sponsoring NCT01296620?

NCT01296620 is sponsored by Tranzyme, Inc..

What drugs are being tested in NCT01296620?

Interventions in NCT01296620: Ulimorelin Intravenously (IV), Ulimorelin Invtravenously (IV), 5% dextrose in water.

What condition does NCT01296620 study?

NCT01296620 studies Gastrointestinal Dysmotility.

Is NCT01296620 still recruiting?

NCT01296620 is currently completed. Last updated 25 July 2012.

Last reviewed 2012-07-25 · How we verify

NCT01296620

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection

Completed Phase 3 Last updated 25 July 2012

What this trial tests

Phase 3 trial testing Ulimorelin Intravenously (IV) in Gastrointestinal Dysmotility in 330 participants. Completed in 1 March 2012.

Timeline

1 February 2011

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	Tranzyme, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	330
Start date	1 February 2011
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	50 locations across United States, Bulgaria, Czechia, France, Lithuania, Romania

Drugs / interventions tested

Ulimorelin Intravenously (IV) — full drug profile →
Ulimorelin Invtravenously (IV) — full drug profile →
5% dextrose in water — full drug profile →

Conditions studied

Gastrointestinal Dysmotility — all drugs for Gastrointestinal Dysmotility →

Sponsor

Tranzyme, Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Gastrointestinal Dysmotility. 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.

Recovery of GI Function
Time frame: up to 7 days of dosing or until hospital discharge

Sponsor's own description

Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Safety and efficacy of ulimorelin administered postoperatively to accelerate recovery of gastrointestinal motility following partial bowel resection: results of two randomized, placebo-controlled phase 3 trials.
Shaw M, Pediconi C, McVey D, Mondou E, et al · · 2013 · cited 37× · PMID 23739196 · DOI 10.1097/dcr.0b013e31829196d0
Future Treatment of Constipation-associated Disorders: Role of Relamorelin and Other Ghrelin Receptor Agonists.
Mosińska P, Zatorski H, Storr M, Fichna J. · · 2017 · cited 13× · PMID 28238253 · DOI 10.5056/jnm16183

Verify or expand the search:

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 NCT01296620 (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 Tranzyme, Inc.
Last refreshed: 25 July 2012

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/NCT01296620.

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