NCT00552565 (ARDIS-1) is a Phase 3 clinical trial of Rezular 15mg in Irritable Bowel Syndrome With Diarrhea, sponsored by AGI Therapeutics, Inc..

Who is sponsoring NCT00552565?

NCT00552565 is sponsored by AGI Therapeutics, Inc..

What drugs are being tested in NCT00552565?

Interventions in NCT00552565: Rezular 15mg, Placebo, Rezular, Rezular.

What condition does NCT00552565 study?

NCT00552565 studies Irritable Bowel Syndrome With Diarrhea.

Is NCT00552565 still recruiting?

NCT00552565 is currently completed. Last updated 10 June 2009.

Last reviewed 2009-06-10 · How we verify

NCT00552565: ARDIS-1

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 Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)

Completed Phase 3 Last updated 10 June 2009

What this trial tests

Phase 3 trial testing Rezular 15mg in Irritable Bowel Syndrome With Diarrhea in 711 participants. Completed in 1 June 2009.

Timeline

1 September 2007

Primary endpoint
1 June 2009

1 June 2009

Quick facts

Lead sponsor	AGI Therapeutics, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	711
Start date	1 September 2007
Primary completion	1 June 2009
Estimated completion	1 June 2009
Sites	1 location across United States

Drugs / interventions tested

Rezular 15mg — full drug profile →
Placebo
Rezular — full drug profile →
Rezular — full drug profile →

Conditions studied

Irritable Bowel Syndrome With Diarrhea — all drugs for Irritable Bowel Syndrome With Diarrhea →

Sponsor

AGI Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 70, any sex, with Irritable Bowel Syndrome With Diarrhea. 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.

Adequate Relief
Time frame: 8 weeks

Sponsor's own description

The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.

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:

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 NCT00552565 (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 AGI Therapeutics, Inc.
Last refreshed: 10 June 2009

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/NCT00552565.

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