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View Clinical Trial (Medical Research Study)
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Amitiza in Constipation Associated With PD (Parkinson's Disease) - NCT00908076-33606 (Clinical Trial 293931)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy293931.aspx
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| City: |
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Tampa |
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State:
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FL |
| Zip Code: |
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33606 |
| Conditions: |
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Parkinson's Disease |
| Purpose: |
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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.
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| Study summary: |
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Parkinson's disease (PD) affects about one million people in the United States. It is a
common neurological condition that is clinically defined by rigidity (muscle stiffness),
bradykinesia (slowness of movement) and tremor. Parkinson's Disease , however, reveals
numerous non-motor symptoms that have been underemphasized. Problematic symptoms include
varying degrees of dementia, psychosis, diminished assertiveness and confidence, general
fatigue, excessive daytime sleepiness, problems with blood pressure, sweating, and bladder,
and a common yet difficult to define sense of "not feeling well".
A commonly missed symptom in Parkinson's patients is constipation. Constipation can be
difficult to treat with current medications available and many are ineffective. Levodopa and
dopamine agonists drugs are useful for motor symptoms in Parkinson's Disease but have no
effect on constipation. Laxatives and enemas provide limited relief with bothersome side
effects. Even fewer drugs have been studied targeting the constipation problem specifically
in the Parkinson's Disease population. Lubiprostone (AMITIZA) is a new medication that has
been studied in the general population for the treatment of chronic constipation. It has
been shown to be a safe and effective medication with few side effects. Lubiprostone has not
yet been studied in the Parkinson's Disease population. We hope to show that this medication
can be safe and effective for constipation in PD patients as well. |
| Criteria: |
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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 |
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| Study is available at: |
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University of South Florida
Tampa, FL 33606
United States
Primary Contact:
Theresa A Zesiewicz, MD
Email: tzesiewi@hsc.usf.edu
Phone: 813-974-5909
Secondary Contact:
Katherine P Harris, LVN
Email: kpharris@bcm.edu
Phone: 713-798-8655 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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