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

This study has been completed.
Sponsor:
Information provided by:
Rottapharm Spain
ClinicalTrials.gov Identifier:
NCT00507715
First received: July 25, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease, Idiopathic
Drug: Plantago ovata husk
Other: hemicellulose crystalline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Clinical Trial to Study the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk

Resource links provided by NLM:


Further study details as provided by Rottapharm Spain:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 18
Study Start Date: September 2006
Study Completion Date: November 2006
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507715

Locations
Spain
Hospital de León
Leon, León, Spain, 24071
Sponsors and Collaborators
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)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00507715     History of Changes
Other Study ID Numbers: PLAN-EC-LDOPA-FI, EudraCT number:2006-000491-33
Study First Received: July 25, 2007
Last Updated: July 25, 2007
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Rottapharm Spain:
Parkinson's Disease, Idiopathic
l-dopa levels
plantago ovata husk

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on October 19, 2014