EUCTR2019-000307-32-DE
Active, not recruiting
Phase 1
Clinical trial for examination of efficacy and safety of MYRRHINIL-INTEST® versus placebo in patients with diarrhea-dominant irritable bowel syndrom (IBS-D) - MINDAS
Repha GmbH0 sites220 target enrollmentMarch 4, 2020
ConditionsConfirmed diagnosis of diarrhea-dominant irritable bowel syndrome (IBS-D) by a specialist physician and/or internal medicine and/or general medicineMedDRA version: 26.0Level: LLTClassification code 10060845Term: Diarrhea predominant irritable bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
DrugsMYRRHINIL-INTEST®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Confirmed diagnosis of diarrhea-dominant irritable bowel syndrome (IBS-D) by a specialist physician and/or internal medicine and/or general medicine
- Sponsor
- Repha GmbH
- Enrollment
- 220
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients of both sexes aged \=18 and \= 75 years
- •confirmed IBS\-D diagnostic to visit 1
- •performed colon examination (coloscopy) by patients \> 55 years within the last 5 years before study participation
- •stool frequency: before visit 1 (screening) in the last 7 days on at least 3 days 1 watery stool/day
- •Evaluation of the IBS\-D symptoms:
- •o NRS pain \> 3 points at visit 1 and visit 2
- •o stool consistency documented by the patient using the Bristol stool form scale to visit 1 and 2
- •Stool sample analysis for exclusion of blood in stool (faecal occult blood) and exclusion of Clostridium difficile infection by Glutamate\-dehydrogenase\- (GDH\-) ELISA by inclusion in the study (results at visit 2\)
- •Presence of an informed consent signed by the patient
- •Understanding that changes in lifestyle and eating habits are avoided during the study period
Exclusion Criteria
- •shortened due to character limit:
- •a) Diseases
- •1\. confirmed diagnosis of microscopic colitis, ulcerative colitis or Crohn's disease
- •2\. confirmed diagnosis of constipation subtype IBS (IBS\-C), mixed\-type IBS (IBS\-M) or undefined IBS (IBS\-U)
- •3\. Since disease: weight loss in the last 6 months (clinically significant, at the investigator's discretion), nocturnal symptoms, anamnesis by first degree relatives with colon carcinoma
- •4\. suspicion of acute appendicitis
- •5\. if stool tests have been performed in the previous 6 months prior to inclusion in the study:
- •\- positive test for blood in stool (except for admixtures due to hemorrhoids or traces of blood due to local irritation due to frequent defecation)
- •\- positive test for parasites and worm eggs
- •\- clinically relevant increased calprotectin values (\> 50 µg/g) in stool
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Clinical trial for examination of efficacy and safety of ANGOCIN® Anti-Infekt N versus placebo in the continous prophylaxis of chronically recurring uncomplicated cystitisContinuous prophylaxis of chronically recurring uncomplicated cystitisMedDRA version: 20.1 Level: LLT Classification code 10011786 Term: Cystitis chronic System Organ Class: 100000004862MedDRA version: 21.1 Level: PT Classification code 10063057 Term: Cystitis noninfective System Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]EUCTR2013-004653-25-DERepha GmbH224
Not yet recruiting
Not Applicable
Clinical trial to investigate the efficacy and safety of fish skin-derived collagen on wall thickness in the carotid artery and clinical symptom, etc. in healthy adults and subjects with mild carotid artery hypertrophy by a double-blind parallel group comparison desigHealthy adults and subjects with mild carotid artery hypertrophyJPRN-UMIN000026277Kojinkai Medical Corporation Shin-Nihonbashi Ishii clinic120
Active, not recruiting
Phase 1
Clinical Trial to investigate the efficacy and safety of ANGOCIN® Anti-Infekt N against placebo preventing urinary tract infections in catheterized patientsProphylaxis of catheter-associated chronically inflammatory recurring urinary tract infections in adult patientsMedDRA version: 20.0Level: LLTClassification code 10046544Term: Urinary infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.0Level: LLTClassification code 10007810Term: Catheter related infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]EUCTR2016-004842-27-DERepha GmbH100
Active, not recruiting
Not Applicable
The effectiveness and safety of oral adhesive bandage for extraction wound managementWound management in tooth extractionOral HealthISRCTN11589028Wuhan University120
Recruiting
Phase 3
Diferent doses of lactase in subjects with intolerance lactoseRBR-53hjzkutracom Indústria e Comércio Ltda.