Overview

Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease

Status:
Completed
Trial end date:
2018-04-01
Target enrollment:
0
Participant gender:
All
Summary
The main objective of this study is to evaluate the efficacy of STW5 Iberogast, over a 28-day period, for the treatment of constipation in parkinsonian patients suffering from gastrointestinal disorders.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nantes University Hospital
Criteria
Inclusion Criteria:

- Patient 30 to 80 years

- Parkinson's disease according to the criteria of the United Kingdom Parkinson's
Disease Society Brain Bank

- Presence of constipation defined by the Rome III criteria Functional constipation

- Social assured Patient

- Patients with signed consent

Exclusion Criteria:

- Organic Affection colic

- Constipation Drug

- Other neurological disorder Parkinson's disease

- Metabolic disease diabetes collagenoses

- Severe renal or hepatic impairment

- Pregnant or lactating women

- Premenopausal women without contraceptive device effective

- Regular and prolonged use of history (> 12 months) of laxatives irritants

- Use of oral laxative treatment in the two weeks before the start of treatment, and
refusal to stop these treatment during the course of the study

- Taking treatment antabuse

- Cognitive impairment compromising understanding or application instructions

- Patient already included in a research protocol

- Minors

- Nobody protected by law