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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02719496
• Date of registration: 15/03/2016
• Prospective Registration: Yes
• Primary sponsor: Nantes University Hospital
• Public title: 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
• Scientific title: 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
• Date of first enrolment: April 2016
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02719496
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Gastrointestinal Disorders in Parkinson's Disease

Intervention(s)

Drug: IBEROGAST

Primary Outcome(s)

increasing the weekly number of exemptions of 3 in the last week of treatment compared with the reference week (Efficacity) [Time Frame: 28 days]

Secondary Outcome(s)

Parkinson Disease Quotation ( PDQ39) (tolerability in parkinsonian) [Time Frame: 28 days]

Short Form Health Survey (SF36) (quality of life) [Time Frame: 28 days]

Incidence of Treatment-Emergent Adverse Events (Tolerability) [Time Frame: 28 days]

motor and non-motor symptoms [Time Frame: 28 days]

use of rectal laxatives [Time Frame: 28 days]

quality of evacuations [Time Frame: 28 days]

clinical global improvement of gastrointestinal symptoms [Time Frame: 28 days]

Gastrointestinal Symptom Rating Scale (quality of life) [Time Frame: 28 days]

Secondary ID(s)

RC15_0396

Source(s) of Monetary Support

Please refer to primary and secondary sponsors