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Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk

NCT ID: NCT00507715

Last Updated: 2007-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease, Idiopathic

Keywords

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Parkinson's Disease, Idiopathic l-dopa levels plantago ovata husk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Plantago ovata husk

Group Type EXPERIMENTAL

Plantago ovata husk

Intervention Type DRUG

5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days

2

hemicellulose crystalline

Group Type PLACEBO_COMPARATOR

hemicellulose crystalline

Intervention Type OTHER

5g effervescent powder t.id. during 14 days

Interventions

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Plantago ovata husk

5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days

Intervention Type DRUG

hemicellulose crystalline

5g effervescent powder t.id. during 14 days

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rottapharm Spain

INDUSTRY

Sponsor Role lead

Principal Investigators

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Sierra Matilde, Ph, phD

Role: STUDY_CHAIR

Departamento de Ciencias Biomédicas de la Facultad de Veterinaria de la Universidad de León, León (Spain)

Carriedo Demetrio, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de León, León (Spain)

Locations

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Hospital de León

León, León, Spain

Site Status

Countries

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Spain

Other Identifiers

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EudraCT number:2006-000491-33

Identifier Type: -

Identifier Source: secondary_id

PLAN-EC-LDOPA-FI

Identifier Type: -

Identifier Source: org_study_id