Trial | NCT00507715  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    18
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.
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 Started
Sep 30
2006
Study Completion
Nov 30
2006
Last Update
Jul 26
2007
Estimate

Drug Plantago ovata husk

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

Other hemicellulose crystalline

5g effervescent powder t.id. during 14 days

1 Experimental

Plantago ovata husk

2 Placebo Comparator

hemicellulose crystalline

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.
No Results Posted