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

July 25, 2007 updated by: Rottapharm Spain

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • León
      • Leon, León, Spain, 24071
        • Hospital de León

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: 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
Other: 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

This is where you will find people and organizations involved with this study.

Sponsor

Rottapharm Spain

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

July 25, 2007

First Submitted That Met QC Criteria

July 25, 2007

First Posted (ESTIMATE)

July 26, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2007

Last Update Submitted That Met QC Criteria

July 25, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

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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