Lubiprostone as a Treatment for Constipation in Parkinson's Disease

NCT00669461 | Terminated Results

• 2 other identifiers: 78055FWA00001119
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Constipation; Parkinson's Disease

Keywords

Constipation; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  up to 6 weeks

Study Arms (1)

Patients

EXPERIMENTAL

Drug: Lubiprostone

Interventions

Lubiprostone DRUG

Lubiprostone 24 mcg BID orally for 4 weeks

Patients

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• Takeda: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Constipation; Parkinson Disease

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Muhannad Heif, MD
• Organization: University of Arkansas for Medical Sciences

mmheif@gmail.com

5016500215

Study Officials

• Muhannad M Heif, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 30, 2008
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 30, 2016
• Results First Posted: May 15, 2012

Record last verified: 2016-11

Locations

US (1)