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
PHYTOPARK
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
March 25, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 24, 2018
April 1, 2018
2 years
March 15, 2016
April 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
increasing the weekly number of exemptions of 3 in the last week of treatment compared with the reference week (Efficacity)
evaluate the efficacy of Iberogast, over a 28-day period, for the treatment of constipation in parkinsonian patients suffering from gastrointestinal disorders.
28 days
Secondary Outcomes (8)
quality of evacuations
28 days
Gastrointestinal Symptom Rating Scale (quality of life)
28 days
Short Form Health Survey (SF36) (quality of life)
28 days
use of rectal laxatives
28 days
clinical global improvement of gastrointestinal symptoms
28 days
- +3 more secondary outcomes
Study Arms (1)
IBEROGAST
EXPERIMENTALDose of 20 drops three times a day for 28 days, on constipation parkinsonian patients with disorders intestinal transit.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tiphaine Rouaud
Nantes, France
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2016
First Posted
March 25, 2016
Study Start
April 1, 2016
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
April 24, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share