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Lubiprostone as a Treatment for Constipation in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00669461
Recruitment Status : Terminated (Lack of recruitment)
First Posted : April 30, 2008
Results First Posted : May 15, 2012
Last Update Posted : December 30, 2016
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
University of Arkansas

Brief 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)

Condition or disease Intervention/treatment Phase
Constipation Parkinson's Disease Drug: Lubiprostone Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lubiprostone as a Treatment for Constipation in Parkinson's Disease
Study Start Date : June 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Patients Drug: Lubiprostone
Lubiprostone 24 mcg BID orally for 4 weeks



Primary Outcome Measures :
  1. Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks [ Time Frame: up to 6 weeks ]
    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 :
  1. Average Number of Spontaneous Bowel Movements (SBM) Per Week [ Time Frame: up to 6 weeks ]
    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)).



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669461


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Takeda
Investigators
Principal Investigator: Muhannad M Heif, MD University of Arkansas

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00669461     History of Changes
Other Study ID Numbers: 78055
78055
FWA00001119
First Posted: April 30, 2008    Key Record Dates
Results First Posted: May 15, 2012
Last Update Posted: December 30, 2016
Last Verified: November 2016

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

Additional relevant MeSH terms:
Parkinson Disease
Constipation
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action