Amitriptyline versus placebo for inducing remission in patients with mild to moderate ulcerative colitis

Phase 3

• Conditions: Health Condition 1: K519- Ulcerative colitis, unspecified

• Registration Number: CTRI/2024/08/071932
• Lead Sponsor: Department of Gastroenterology AIIMS Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients who are confirmed cases of mild to moderate Ulcerative Colitis as assessed by SCCAI score (3-9)

2. Endoscopically active disease (UCEIS more than 1) or fecal calprotectin more than 150 µg/g.

3. Age: 18 – 70 years

4. Patients who are on optimum dosage of oral (minimum 2.4 g per day) and topical 5-ASA agents, are oral steroid naïve or experienced (last dose more than 8 weeks prior) but not on Steroids.

5. Anti-TNF/Anti-integrin naïve or experienced (intolerant or non-responder) but last dose =2 months back.

6. Concomitant therapy allowed -

a. Topical steroid and topical 5-ASA therapy (if stable for last 2 weeks)

b. Patients on stable doses of oral 5-ASA (5-amino salicylic acid) for past 2 weeks.

c. Patients on stable doses of azathioprine for past 2 weeks.

d. Patients on advanced therapy (stable doses of biologicals, tofacitinib or vedolizumab for past 8 weeks)

7. Women of childbearing age should agree to avoid conception during the study period.

8. Patients giving written informed consent

Exclusion Criteria

1.Severe disease SCCAI more than or equal to 10

2.Patients with fulminant colitis requiring hospitalization

3.Use of oral steroids, antibiotics, Anti-TNF/Anti-integrin agents, small molecule inhibitors within the past 8 weeks.

4.Patients with surgical intervention for IBD, on psychiatric medication or pregnant and lactating women

5.Patients with bipolar, psychotic, substance use disorders, major depressive disorder or anxiety disorders.

6.Patients with Severe comorbid medical illness

a.Cardiac: NYHA II or higher congestive heart failure

b.Renal: Creatine clearance (Cockcroft Gault formula) less than 40 ml/min

c.Severe hepatic impairment

d.Malignancies or a history of malignancies

e.Significant trauma or major surgery within 4 weeks

f.History of bowel surgery within 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified