ulcerative colitis patients in clinical remission MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Conditions
Interventions
Trade Name: Myrrhinil-Intest®
Pharmaceutical Form: Coated tablet
INN or Proposed INN: MATRICARIA FLOWER
Other descriptive name: MATRICARIA FLOWER
Concentration unit: mg milligram(s)
Concentration type
Sponsors
REPHA GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to confirm Myrrhinil-Intest's non-inferiority versus mesalazine concerning the activity of ulcerative colitis in remission over the treatment period. ;Secondary Objective: Efficacy parameters: Duration until relapse; general condition assessment by the physician and patient; social activity of the patient; constitution of the patient; efficacy assessment by the physician; quality of life; inflammatory parameters: lactoferrine, pmn elastase and calprotectin; mucosal healing; histologic healing Safety parameters: adverse events; blood count: CRP, leukocytes, thrombocytes, Hb, serum creatinine, AST and ALT, blood sedimentation rate; vital signs; tolerance of the investigational product; occurrence of relapses in patients; relapse rate ;Primary end point(s): The primary endpoint is the averaged colitis activity index (defined by Rachmilewitz) of a patient over the treatment period. | — |
Countries
Germany
Outcome results
None listed