Amitiza in Constipation Associated With PD (Parkinson's Disease)

NCT00908076 | Completed Phase 4 Results

• 1 other identifier: H-21192
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe and effective for chronic constipation, will also improve constipation symptoms in Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in bowel movement consistency, quality of life and motor symptoms.

Conditions

Parkinson's Disease

Keywords

constipation; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to End of Study

  Global impression of change, stool diary, visual analog scale of improvement, UPDRS rating scale and constipation questionnaires. The primary efficacy data will be analyzed using Student's t-test with unequal variances as the difference from baseline in SBM comparing cases and controls, using last observation carried forward for missing data in the intent-to-treat population.

  Baseline to end of study

Study Arms (2)

amitiza

ACTIVE COMPARATOR

Amitiza

Drug: LUBIPROSTONE

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: LUBIPROSTONE

Interventions

LUBIPROSTONE DRUG

Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.

Placebo; amitiza

Eligibility Criteria

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

You may qualify if:

• \. Subjects must be diagnosed with PD according to conventional criteria.
• \. Subjects must report having constipation and fulfill Rome III criteria19 for chronic constipation: at least 3 months, in the last 6 months with two or more of the following: i. Less than 3 SBM's per week ii. Straining with defecation more than 25% of the time iii. Lumpy or hard stools with defecation more than 25% of the time iv. Sensation of incomplete evacuation with defecation more than 25% of the time v. Sensation of anorectal obstruction or blockage with defecation more than 25% of the time vi. Use of manual maneuvers to facilitate defecation more than 25% of the time
• \. Patients will be encouraged to use only lubiprostone for constipation. If they use any other agents they will need to record this use in their diary; any BM that occurs within 24 hours of the other agent used will be recorded, but not be counted as a SBM.
• \. Patients or patients' caretaker(s)/ legal guardian must be able to read, understand, and accurately record data into the diary to guarantee full participation in the study.
• \. Patients over the age of 50 must have had a colonoscopy or sigmoidoscopy within 5 years.
• \. Patients or patient's caretaker(s)/legal guardian must be willing and able to provide informed consent before beginning the study.

You may not qualify if:

• Evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit including gastric, small bowel or colonic resection (appendectomy, cholecystectomy, benign polypectomy are allowed); history of colon cancer, history of inflammatory bowel disease (Crohn's disease or ulcerative colitis); insulin-dependent diabetes mellitus, history of Hirschsprung's disease, progressive systemic sclerosis (scleroderma), anorexia nervosa; other diseases or conditions that in the opinion of the investigator significantly affect bowel transit. Subjects with constipation secondary to any other documented cause.
• Planned use of drugs or agents during pretreatment phase onward that affect gastrointestinal motility and/ or prescription including laxatives including stool softeners (patients experiencing significant constipation may use a laxative as rescue medication if needed); antidiarrheals (in case of significant diarrhea loperamide may be used if needed); antacids containing magnesium or aluminum salts (only calcium containing ones are allowed); anticholinergics, antispasmodic agents (e.g., Librax, Donnatal, dicyclomine); erythromycin and other macrolides; octreotide; ondansetron or other 5-HT3 antagonists; opioids/narcotic analgesics; prokinetics (metoclopramide); serotonin re-uptake inhibitors or tricyclic antidepressants (allowed if constant doses for at least 1 month before treatment); calcium antagonists (allowed if constant doses for at least 1 month before treatment).
• Subjects with any significant cardiovascular, liver, lung, renal, psychiatric or neurological diseases (not including PD).
• Patients with previous allergic reaction or lack of tolerability to lubiprostone.
• Current or recent history (within 12 months) of drug or alcohol abuse.
• Pregnancy or breast feeding.
• Fertile women (defined as those who are not surgically sterile, are not \>1 year post-menopausal or who are not currently using or complying with a medically approved method of contraception). Lubiprostone has not been studied in pregnant women and should only be used during a pregnancy if the potential benefits justify the potential risk to the fetus. Women should have a negative pregnancy test before beginning treatment with lubiprostone and need to practice effective contraceptive measures

Sponsors & Collaborators

• Baylor College of Medicine: lead
• University of South Florida: collaborator

Study Sites (2)

University of South Florida

Tampa, Florida, 33606, United States

Location

Baylor College of Medicine PDCMDC

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Ondo WG, Kenney C, Sullivan K, Davidson A, Hunter C, Jahan I, McCombs A, Miller A, Zesiewicz TA. Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease. Neurology. 2012 May 22;78(21):1650-4. doi: 10.1212/WNL.0b013e3182574f28. Epub 2012 May 9.

  PMID: 22573627 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Constipation

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Christine Hunter
• Organization: Baylor College of Medicine

chunter@bcm.edu

713-798-6556

Study Officials

• William G Ondo, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 25, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 29, 2022
• Results First Posted: August 26, 2016

Record last verified: 2022-12

Locations

US (2)