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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
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

April 28, 2008
April 16, 2012
June 2009
September 2010   (final data collection date for primary outcome measure)
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).
Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline. [ Time Frame: Daily for 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00669461 on ClinicalTrials.gov Archive Site
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)).
1. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. 2. Lubiprostone will improve health related quality of life in subjects with PD induced constipation. [ Time Frame: daily for 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Lubiprostone as a Treatment for Constipation in Parkinson's Disease
Lubiprostone as a Treatment for Constipation in Parkinson's Disease

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)
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Constipation
  • Parkinson's Disease
Drug: Lubiprostone
Lubiprostone 24 mcg BID orally for 4 weeks
Experimental: Patients
Intervention: Drug: Lubiprostone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00669461
78055, 78055, FWA00001119
No
University of Arkansas
University of Arkansas
Takeda
Principal Investigator: Muhannad M Heif, MD University of Arkansas
University of Arkansas
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP