- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00507715
Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
Clinical Trial to Study the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although the treatment with l-dopa is the election treatment for Parkinson´s disease, a high number of patients develop motor complications, including, fluctuations and dyscinesia after some years of treatment.
The origin of the fluctuations is not well established, but it could be attributed, al least partially, a pharmacokinetics factors. So that, it could improve the answer and reduce the adverse reaction if we reach more stable levels of L-dopa in the circulation. The first experimental studies in animals showed that Plantago ovata husk has an influence in the pharmacokinetics parameters of L-dopa, obtaining more stable levels.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
León
-
Leon, León, Spain, 24071
- Hospital de León
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with diagnostic of idiopathic Parkinson disease, with well controlled symptomatology with administration of l-dopa/carbidopa.
- At least 3 months of treatment continued of levodopa.
- Patients that give the their consent to participate in the study.
Exclusion Criteria:
- Patients with diagnostic of idiopathic Parkinson disease, with bad controlled symptomatology with administration of l-dopa/carbidopa.
- Patients with allergic predisposition to Plantago ovata husk or other contraindications for its use.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Plantago ovata husk
|
5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d.
during 14 days
|
PLACEBO_COMPARATOR: 2
hemicellulose crystalline
|
5g effervescent powder t.id.
during 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa.
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate if the treatment with Plantago ovata husk modifies the biochemical parameters as total cholesterol, HDL y LDL, glycaemia, etc.
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sierra Matilde, Ph, phD, Departamento de Ciencias Biomédicas de la Facultad de Veterinaria de la Universidad de León, León (Spain)
- Principal Investigator: Carriedo Demetrio, MD, Hospital de León, León (Spain)
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAN-EC-LDOPA-FI
- EudraCT number:2006-000491-33
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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