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Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Primary Purpose

Constipation, Parkinson's Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lubiprostone
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation, Parkinson's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Outcomes

Primary Outcome Measures

Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 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

Average Number of Spontaneous Bowel Movements (SBM) Per Week
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)).

Full Information

First Posted
April 28, 2008
Last Updated
November 9, 2016
Sponsor
University of Arkansas
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00669461
Brief Title
Lubiprostone as a Treatment for Constipation in Parkinson's Disease
Official Title
Lubiprostone as a Treatment for Constipation in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Parkinson's Disease
Keywords
Constipation, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Intervention Description
Lubiprostone 24 mcg BID orally for 4 weeks
Primary Outcome Measure Information:
Title
Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks
Description
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).
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Average Number of Spontaneous Bowel Movements (SBM) Per Week
Description
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)).
Time Frame
up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 50-85 years Diagnosis of Parkinson's disease Constipation as defined by the Rome III committee BSFS of more or equal to 1 and less or equal to 3 Normal colonoscopy in the last 5 years( normal defined as absence of obstructive lesions in the colon) All women subjects will be post menopausal or surgically sterile. Exclusion Criteria: Known hypersensitivity reaction to Amitiza ( Lubiprostone) Known significant adverse effects to previous treatment with Lubiprostone which include; new or worsening abdominal pain, severe diarrhea, nausea, vomiting, and severe headache. Renal dysfunction with creatinine clearance less than 15 ml/min Abnormal liver enzymes or history of chronic liver disorder History of bowel obstruction, , or abdominal adhesions . Abnormal Colonoscopy ( obstructive lesions within the colon) Inability to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhannad M Heif, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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Lubiprostone as a Treatment for Constipation in Parkinson's Disease

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