Who is sponsoring NCT05249725?

NCT05249725 is sponsored by Lee's Pharmaceutical Limited.

What drugs are being tested in NCT05249725?

Interventions in NCT05249725: Irsogladine Maleate, Hydrotalcite.

What condition does NCT05249725 study?

NCT05249725 studies NSAIDs-associated Intestinal Mucosal Injury.

Is NCT05249725 still recruiting?

NCT05249725 is currently status unknown. Last updated 23 March 2022.

Last reviewed 2022-03-23 · How we verify

NCT05249725

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

Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population

Status unknown Phase 4 Last updated 23 March 2022

What this trial tests

Phase 4 trial testing Irsogladine Maleate in NSAIDs-associated Intestinal Mucosal Injury in 100 participants. Status unknown.

Timeline

1 April 2022

Primary endpoint
1 August 2022

1 April 2023

Quick facts

Lead sponsor	Lee's Pharmaceutical Limited
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	100
Start date	1 April 2022
Primary completion	1 August 2022
Estimated completion	1 April 2023

Drugs / interventions tested

Irsogladine Maleate — full drug profile →
Hydrotalcite — full drug profile →

Conditions studied

NSAIDs-associated Intestinal Mucosal Injury — all drugs for NSAIDs-associated Intestinal Mucosal Injury →

Sponsor

Lee's Pharmaceutical Limited — full company profile →

Who can join

Adults 20 to 80, any sex, with NSAIDs-associated Intestinal Mucosal Injury. 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.

Number of small intestinal mucosal lesions under capsule endoscopy
Time frame: 8 weeks
After 8 weeks of treatment, capsule endoscopy was repeated, and the number of small intestinal mucosal lesions under the microscope decreased by ≥1 or the Lewis score decreased by more than before, which was considered effective.

Sponsor's own description

All patients who met the inclusion criteria and agreed to participate in the study underwent baseline capsule endoscopy. Patients with intestinal mucosal injury detected during the initial capsule endoscopy were randomly divided into isoladin maleate group or magnesium aluminum carbonate control group using computer-generated random numbers. Patients in the isoladine maleate group received 4 mg isoladine maleate (Gesellon, Japan) every morning for 4 weeks (or 8 weeks, duration to be determined); Magnesium aluminum carbonate control group received 1 g magnesium aluminum carbonate every morning, afternoon and evening for 4 weeks (or 8 weeks, course to be determined). After treatment, capsule endoscopy was performed again to evaluate the healing of intestinal mucosa.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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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 NCT05249725 (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 Lee's Pharmaceutical Limited
Last refreshed: 23 March 2022

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/NCT05249725.

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