FindTrial
Sign In

Clinical trial with Transidose (=Lactulose) for oral intake regarding efficacy and safety in patients suffering from constipation.

Clinical trial to evaluate the efficacy and safety of oral Transidose in patients suffering from constipation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-002900-15-DE
Enrollment
Unknown
Registered
2014-03-04
Start date
2014-04-28
Completion date
Unknown
Last updated
2016-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation MedDRA version: 18.1 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Transidose Product Code: Transidose Pharmaceutical Form: Oral paste INN or Proposed INN: LACTULOSE CAS Number: 4618-18-2 Concentration unit: g gram(s) Concentration type: equal Concentra

Sponsors

Salsarulo Pharma
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Alarm symptoms Organic inflammatory bowel disease GI obstruction, subocclusive syndromes

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): Bloating, pain, malaise, excessive straining, unsatisfactory defecatiOJ:lS, Bristol Stool Form Scale;Timepoint(s) of evaluation of this end point: T-7 days, baseline, 1 week, 2 weeks of active tratment—

Countries

Germany

Contacts

Public ContactGilles Salsarulo

Salsarulo Pharma

gilles.salsarulo@salsapharma.com0033618920891

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026