Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00669461
• Other study ID #: 78055
• Secondary ID: 78055FWA00001119
• Status: Terminated
• Phase: N/A
• First received: April 28, 2008
• Last updated: April 16, 2012
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: April 2012
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Lubiprostone
Lubiprostone 24 mcg BID orally for 4 weeks

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to 6 weeks	No
Secondary	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)).	up to 6 weeks	No