Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRC

• Conditions: ulcerative colitis patients in clinical remission; MedDRA version: 9.1Level: LLTClassification code 10045365Term: Ulcerative colitis

• Registration Number: EUCTR2007-007928-18-DE
• Lead Sponsor: REPHA GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-12
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-patients of both gender, = 18 years of age
-patients diagnosed with ulcerative colitis (clinical, endoscopic, histological) and in remission between 1 week and 1 year according to colitis activity index (CAI, defined by Rachmilewitz) = 4 at enrollment
-signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-use of steroids or antibiotics for ulcerative colitis together with the investigational procuct
-intake of Escherichia coli Nissle and Psyllii semen together with the investigational product
-administration of the following drugs within the previous 3 months before trial entry and during the trial: 'biologicals' (Infliximab, Mycophenolat, Tacrolimus, Thalidomid), other drugs to modify immune response (Methotrexat, Azathioprin) or/and drugs in clinical development
-total parenteral nutrition, formula diet
-infectious or chronic active ulcerative colitis
-active ulcerative colitis at trial entry
-condition after complete colectomy
-malignant tumor disease within the last 5 years and/or malignant tumor disease older than 5 years which can not be considered cured according to the investigator's judgement (except superficial basal cell, squamous cell carcinoma, or basalioma of the skin which has been completely resected or can be considered cured) or/and clinical significant cardiac, hepatic or renal dysfunctions or diseases of the CNS, lung, immune system or gastro-intestinal diseases (in addition to ulcerative colitis)
-known alcohol or drug abuse
-known intolerance to the ingredients
-pregnancy or in the physician's opinion unreliable contraception for women of childbearing years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified