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Lubiprostone as a Treatment for Constipation in Parkinson's Disease

NCT00669461 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2016-12-30

Study results available
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Summary

Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic transit time in healthy volunteers in addition to activating the chloride channels in the intestinal cells, it has the potential to improve constipation in patients with PD with no subsequent adverse events on the control of the neurological manifestation of PD. So we hypothesize the following:

1. Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary)
2. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary)
3. Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)

Conditions

Interventions

DRUG

Lubiprostone

Lubiprostone 24 mcg BID orally for 4 weeks

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Muhannad M Heif, MD · University of Arkansas

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00669461 on ClinicalTrials.gov