Back to resultsStudy of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
Primary Purpose
Parkinson's Disease, Idiopathic
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Plantago ovata husk
hemicellulose crystalline
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease, Idiopathic focused on measuring Parkinson's Disease, Idiopathic, l-dopa levels, plantago ovata husk
Eligibility Criteria
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.
Sites / Locations
- Hospital de León
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Plantago ovata husk
hemicellulose crystalline
Outcomes
Primary Outcome Measures
To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa.
Secondary Outcome Measures
To evaluate if the treatment with Plantago ovata husk modifies the biochemical parameters as total cholesterol, HDL y LDL, glycaemia, etc.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00507715
Brief Title
Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
Official Title
Clinical Trial to Study the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rottapharm Spain
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to study the effect of the association levodopa/carbidopa with plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being treated with levodopa/carbidopa.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Idiopathic
Keywords
Parkinson's Disease, Idiopathic, l-dopa levels, plantago ovata husk
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Plantago ovata husk
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
hemicellulose crystalline
Intervention Type
Drug
Intervention Name(s)
Plantago ovata husk
Intervention Description
5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days
Intervention Type
Other
Intervention Name(s)
hemicellulose crystalline
Intervention Description
5g effervescent powder t.id. during 14 days
Primary Outcome Measure Information:
Title
To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sierra Matilde, Ph, phD
Organizational Affiliation
Departamento de Ciencias Biomédicas de la Facultad de Veterinaria de la Universidad de León, León (Spain)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carriedo Demetrio, MD
Organizational Affiliation
Hospital de León, León (Spain)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de León
City
Leon
State/Province
León
ZIP/Postal Code
24071
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
We'll reach out to this number within 24 hrs