A clinical trial to study the effects of mesalamine suppositories and reference drug Canasa suppositories in patients with mild to moderate active Ulcerative Proctitis.

Phase 3

Completed

• Conditions: Ulcerative (chronic) proctitis,

• Registration Number: CTRI/2010/091/000519
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Ulcerative proctitis is a common form of the inflammatory bowel disease called ulcerative colitis. This will be a therapeutic equivalence trial wherein it is proposed to study the therapeutic equivalence of the test drug to Canasa® 1000 mg Suppositories and superiority of the test drug to placebo using clinical and endoscopic endpoints for efficacy assessment. The present study is planned to study the safety and efficacy of Mesalamine suppositories, 1000 mg (Zydus, CHL) Versus a reference arm evaluating Canasa®1000 mg (Mesalamine) suppositories (Axcan Pharma), in the treatment of mild to moderate active Ulcerative Proctitis. The efficacy and safety of Mesalamine has been well established in several clinical trials carried out internationally in patients with ulcerative colitis. This will be a therapeutic equivalence trial wherein it is proposed to study the therapeutic equivalence of the test drug to Canasa® 1000 mg Suppositories and superiority of the test drug to placebo using clinical and endoscopic endpoints for efficacy assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-08
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Subjects must provide the written informed consent prior to any study related activity/procedure being performed.
• Subjects must be 18 years of age or older with no known medical conditions that, in the investigator?s opinion, may interfere with study participation.
• Newly diagnosed or relapsing (relapsed ≤ 6 weeks prior to randomisation) active Ulcerative proctitis (score of 4?10 on a modified UC?DAI score).
• Diagnosis and scoring shall be based on the results of sigmoidoscopy/colonoscopy and biopsy, which shall be done within 2 weeks prior to randomization, and recall of symptoms of rectal bleeding and stool frequency of last 3 days before screening of the subjects.
• Inflammation extending at least 5 cm and no more than 15 cm above the anal margin confirmed by sigmoidoscopy or colonoscopy.
• The sigmoidoscopy / colonoscopy score should be ≥ 1 for inclusion of subject.
• Physician?s Global Assessment (PGA) score of 1 or 2.
• Subject must understand and be able, willing and likely to fully comply with the study procedures and restrictions.

Exclusion Criteria

• Subject is contraindicated to the use of 5-ASA or having known or suspected allergy to 5-ASA or salicylic acid (i.e. aspirin).
• Non-response to rectal 5-ASA therapy or to oral 5-ASA therapy at a dose > 2.4g/day for induction of remission within the previous year.3. Previously failed to respond to steroids within the previous year.4. Current relapse lasting more than 6 weeks prior to randomization.5. Crohn?s disease, any active peptic ulcer disease, bleeding disorders, short bowel syndrome or history of bowel surgery in the past, except appendectomy.6. In the opinion of investigator if subject has immediate or significant risk of toxic megacolon.
• Impaired renal function (creatinine > 1.2 mg %) or impaired hepatic function (AST/ALT > 2 times UNL).
• Subjects known to be HBsAg or Hepatitis C antibody positive.9. Severe UC defined by the following criteria:6 bloody stools daily with one or more of the following: a)Oral temperature > 37.8°C b)Pulse rate > 90/min c)Hemoglobin < 10 g/dL10.
• Stools showing positive culture for enteric pathogens (Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas or Campylobacter) or those with Clostridium difficile toxin present or with ova or parasites as detected by microscopy.11.
• The following treatment will be forbidden during the study (if present at selection, a wash-out will be necessary): a)Loperamide and other antidiarrhoeal agents, mucilages, antibiotics: 1 week wash-out.
• b)Oral or rectal steroids: 4 weeks wash-out.
• c)Repeated treatment (> 3days of use) of non steroidal anti-inflammatory drugs (NSAID) oral or rectal route: 1 week wash-out (aspirin ≤ 325 mg/day used for cardioprotection is allowed).
• d)Sulfasalazine > 2.4g/day or mesalazine or 4-ASA at a higher dose than what is permitted in the local formulary or standard care for maintenance treatment: 4 weeks wash-out e)Immunomodulating/suppressing drugs: 6 weeks wash out.
• f)Probiotics: 1 Week12.
• Pregnant, nursing mothers or any subject planning a pregnancy within the next 2 months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: sterilisation, Intrauterine device [IUD], oral contraceptives or double barrier methods).13.Participation in another clinical trial or having taken an experimental drug within last 30 days prior to the study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Percentage of patients who are in remission (clinical and endoscopic)	Day 21 to 28

Secondary Outcome Measures

Name	Time	Method
3. To compare the percentage of patients achieving clinical improvement (defined as a decrease of ≥ 3 points from baseline in the total modified UC-DAI score)	Week 6
6. To compare the changes in sigmoidoscopic (mucosal) appearance among the three different treatment groups	From baseline to 6 weeks of treatment
1.Percentage of patients who are in remission (clinical and endoscopic)	Week 6
2. To compare the ability of three products with respect to maintaining remission	week 6
4. To compare the the percentage of patients achieving clinical remission or improvement (defined as a score of 0 points for stool frequency and rectal bleeding)among the three different treatment groups	Week 6
5. To compare the change in the modified UC-DAI score between the three different treatment groups.	Baseline to 6 weeks of treatment
7. To compare the change in symptoms (rectal bleeding and Stool frequency) among the three treatment groups	From baseline to 4 and 6 weeks of treatment

Trial Locations

Locations (32)

1Private Clinic; 🇮🇳 Ashok, India

201, Silver brook A, Opp. Doctor house; 🇮🇳 Ahmadabad, GUJARAT, India

Aayush GI Care; 🇮🇳 Mumbai, MAHARASHTRA, India

Alka Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Ameeta Poly Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Asopa Hospital & Research Centre; 🇮🇳 Agra, UTTAR PRADESH, India

Astha Hospital; 🇮🇳 Dehradun, UTTARANCHAL, India

City Hospital & Gastroenterology Research Centre; 🇮🇳 Patan, GUJARAT, India

Dhruvi Endoscopy & Liver Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Gastrocare Clinic; 🇮🇳 Rajkot, GUJARAT, India

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1Private Clinic

🇮🇳Ashok, India

Dr Peeyush Mishra

Principal investigator

peeyush_m@rediffmail.com