Clinical trial with Transidose (=Lactulose) for oral intake regarding efficacy and safety in patients suffering from constipation.
- Conditions
- ConstipationMedDRA version: 18.1Level: PTClassification code 10010774Term: ConstipationSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-002900-15-DE
- Lead Sponsor
- Salsarulo Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Stool frequency less than 3 stools per week
Compliance with ROME Ill criteria
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Alarm symptoms
Organic inflammatory bowel disease
GI obstruction, subocclusive syndromes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of the efficacy and safety of Transidose p.o.;Secondary Objective: Not applicable;Primary end point(s): Number of stools per week after 2 weeks of active treatment;Timepoint(s) of evaluation of this end point: At the end of the 2-weeks treatment period
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Bloating, pain, malaise, excessive straining, unsatisfactory defecatiOJ:lS,<br>Bristol Stool Form Scale;Timepoint(s) of evaluation of this end point: T-7 days, baseline, 1 week, 2 weeks of active tratment