Amitiza in Constipation Associated With PD (Parkinson's Disease)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Constipation
Intervention: LUBIPROSTONE
Intervention description: 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.
Intervention MeSH terms: Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: constipation; Parkinson's disease

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Subjects must be diagnosed with PD according to conventional criteria.

          -  2. 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

          -  3. 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.

          -  4. 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.

          -  5. Patients over the age of 50 must have had a colonoscopy or sigmoidoscopy within 5
             years.

          -  6. Patients or patient's caretaker(s)/legal guardian must be willing and able to
             provide informed consent before beginning the study.

        Exclusion Criteria:

          -  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