Lubiprostone as a Treatment for Constipation in Parkinson's Disease

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

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:

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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)).

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 85 Years (Adult, Older Adult)
• 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

Contacts and Locations

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

More Information

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT00669461
• Other Study ID Numbers: 78055; 78055; FWA00001119
• First Posted: April 30, 2008
• 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; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Lubiprostone; Chloride Channel Agonists; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action