Who is sponsoring NCT05091775?

NCT05091775 is sponsored by Shiraz University of Medical Sciences.

What drugs are being tested in NCT05091775?

Interventions in NCT05091775: Asacol is used to treat and prevent mild to moderate acute fissure disease.

What condition does NCT05091775 study?

NCT05091775 studies Fissure in Ano, Diarrhea.

Is NCT05091775 still recruiting?

NCT05091775 is currently completed. Last updated 25 October 2021.

Last reviewed 2021-10-25 · How we verify

NCT05091775

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

The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure

Completed Phase 1, PHASE2 Last updated 25 October 2021

What this trial tests

Phase 1, PHASE2 trial testing Asacol is used to treat and prevent mild to moderate acute fissure disease in Fissure in Ano in 140 participants. Completed in 10 January 2021.

Timeline

1 June 2020

Primary endpoint
2 August 2020

10 January 2021

Quick facts

Lead sponsor	Shiraz University of Medical Sciences
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	140
Start date	1 June 2020
Primary completion	2 August 2020
Estimated completion	10 January 2021
Sites	1 location across Iran

Drugs / interventions tested

Asacol is used to treat and prevent mild to moderate acute fissure disease — full drug profile →

Conditions studied

Fissure in Ano — all drugs for Fissure in Ano →
Diarrhea — all drugs for Diarrhea →

Sponsor

Shiraz University of Medical Sciences

Who can join

Adults 18 to 65, any sex, with Fissure in Ano or Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Anal fissure define as a superficial tearing in mucosa on the anoderm surface distal to dentate line . The most important factor is hard stool passing with trauma to anal mucosa. But, diarrhea diarrhea has been another important etiology that happen after some conditions like gastroenteritis, laxative over use, during chemotherapy, and ulcerative colitis exacerbation . In these conditions, it seems the change of stool PH maybe the main reason of inflammation and ulcer in acute phase. The treatment of acute is medical management with change in bowel habits and conservative therapy such as local lubricant, local vasodilator, and warm sitz bath to improve blood supply and wound healing. This research clinical trial is designed to show the effect of Asacol suppository in the management of acute fissure due to diarrhea. The hypothesis of this research clinical trial has been referred to the cause of acute fissure ulcer because of diarrhea.

Publications & conference data

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

Advancements in Rectal Drug Delivery Systems: Clinical Trials, and Patents Perspective.
Rathi R, Sanshita, Kumar A, Vishvakarma V, et al · · 2022 · cited 41× · PMID 36297645 · DOI 10.3390/pharmaceutics14102210

Verify or expand the search:

Other recruiting trials for Fissure in Ano

Currently open trials in the same condition.

NCT03855046 — Complex Treatment of a Chronic Anal Fissure · Phase 4 · recruiting

Other Shiraz University of Medical Sciences trials

Trials by the same sponsor.

NCT07254221 — Rosuvastatin for Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients · Phase 4 · not yet recruiting
NCT06509893 — Ticagrelore Alone Post PCI · Phase 4 · recruiting
NCT05876819 — Quality of Care and Welfare Services for Disabled Middle Older Adults in Iran Lebanon · enrolling by invitation
NCT06979427 — CTFFR and Prediction of Non-Significant CAD Lesions · NA · recruiting
NCT05711004 — Efficacy of Education Via Phone-based Text Messaging (SMS) on Patients With Uncontrolled Hypertension · NA · unknown

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 NCT05091775 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Shiraz University of Medical Sciences
Last refreshed: 25 October 2021

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/NCT05091775.

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