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Lubiprostone as a Treatment for Constipation in Parkinson's Disease

This study has been terminated.
(Lack of recruitment)
Sponsor:
Collaborator:
Takeda Global Research & Development Center, Inc.
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00669461
First received: April 28, 2008
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  Purpose

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)

Condition Intervention
Constipation
Parkinson's Disease
 Drug: Lubiprostone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone).


Secondary Outcome Measures:
  • Average Number of Spontaneous Bowel Movements (SBM) Per Week [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    Average number of spontaneous bowel movements (SBM) per week,measured at baseline, at end of 4 weeks of treatment with Lubiprostone and at 2 weeks after stopping Lubiprostone (( so measure was reported at end of week # 1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone)).


Enrollment: 1
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients Drug: Lubiprostone
Lubiprostone 24 mcg BID orally for 4 weeks

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 50-85 years
  2. Diagnosis of Parkinson's disease
  3. Constipation as defined by the Rome III committee
  4. BSFS of more or equal to 1 and less or equal to 3
  5. Normal colonoscopy in the last 5 years( normal defined as absence of obstructive lesions in the colon)
  6. All women subjects will be post menopausal or surgically sterile.

Exclusion Criteria:

  1. Known hypersensitivity reaction to Amitiza ( Lubiprostone)
  2. Known significant adverse effects to previous treatment with Lubiprostone which include; new or worsening abdominal pain, severe diarrhea, nausea, vomiting, and severe headache.
  3. Renal dysfunction with creatinine clearance less than 15 ml/min
  4. Abnormal liver enzymes or history of chronic liver disorder
  5. History of bowel obstruction, , or abdominal adhesions .
  6. Abnormal Colonoscopy ( obstructive lesions within the colon)
  7. Inability to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669461

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Takeda Global Research & Development Center, Inc.
Investigators
Principal Investigator: Muhannad M Heif, MD University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00669461     History of Changes
Other Study ID Numbers: 78055, 78055, FWA00001119
Study First Received: April 28, 2008
Results First Received: October 25, 2011
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Constipation
Parkinson's Disease

Additional relevant MeSH terms:
Constipation
Parkinson Disease
Signs and Symptoms, Digestive
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 16, 2013