To evaluate efficacy, safety and tolerability of two dose strengths of tacrolimus lipid suspension for injection rectally administered in adult patients with ulcerative colitis

A double-blind, randomized, two-arm, parallel, clinical study to evaluate efficacy, safety and tolerability of two dose strengths of tacrolimus lipid suspension for injection rectally administered in adult patients with mild to moderately active left-sided/distal ulcerative colitis including proctosigmoiditis/proctitis refractory to mesalamine treatment - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/10/006252

Enrollment

Registered

2015-10-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K519- Ulcerative colitis, unspecified

Interventions

Intervention1: Tacrolimus 2 mg: Dose-2 mg,Frequency-60 mL / Once a day,Mode of Administration-Rectally administered,Duration of treatment-4 weeks Control Intervention1: Tacrolimus 4 mg: Dose-4 mg,Freq

Eligibility

Inclusion criteria

Inclusion criteria: 1.Documented history of idiopathic ulcerative colitis based on standard endoscopic (colonoscopic) and histological criteria with mild to moderate active disease 2.Subjects with a modified Ulcerative Colitis Disease Activity Index (UCDAI) score of 4-10 3.Rectal bleeding score of 1 or more 4.Mucosal appearance score of 1 point or more at baseline

Exclusion criteria

Exclusion criteria: 1.Documented history of proximal or universal ulcerative colitis 2.Patients who demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis. 3.Prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations. 4.Patients stool contains enteric pathogens or Clostridium difficile toxins.

Design outcomes

Primary

Measure	Time frame
To examine the efficacy of a four week treatment of two doses of tacrolimus lipid suspension for injection in patients of distal ulcerative colitis refractory to mesalamine treatment.Timepoint: To end of the study	—

Secondary

Measure	Time frame
1. To evaluate the adverse event (AE) profile of tacrolimus lipid suspension for injection preparations. 2. To estimate the plasma level of tacrolimus following its local administration.Timepoint: To end of the study	—

Countries

India

Contacts

Public ContactDr Falgun Vyas

Lambda Therapeutic Research Ltd

Randhirsinh@lambda-cro.com07940202070

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 15, 2026