Status:
COMPLETED
Lubiprostone and Mucus Secretion in Patients With Chronic Constipation
Lead Sponsor:
Texas Tech University Health Sciences Center, El Paso
Conditions:
Constipation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators hypothesize that the symptoms of chronic constipation in some patients are developed due to diminished production and secretion of the alimentary tract mucus resulting in poor lubric...
Detailed Description
Specific Aim 1. To test the effect of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucus production in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal co...
Eligibility Criteria
Inclusion
- Asymptomatic Volunteers:
- 18-65 years of age
- Capable of and willing to give informed consent, and willing to comply with all study requirements
Exclusion
- Pregnancy or lactation
- Subjects unwilling to practice adequate contraception throughout the screening period through 14 days after study termination
- Illegal use of illegal drugs
- Regular consumption of 2 or more drinks of alcohol per day
- Chronic non-steroidal anti- inflammatory drugs (NSAID) use
- Chronic use of H2 receptor antagonists or Proton Pump Inhibitors (PPIs) within 14 days prior to screening
- History of gastric of duodenal ulcer or chronic non-ulcer dyspepsia
- Positive Helicobacter pylori (H. pylori) serology
- Patients with Chronic Constipation:
- Inclusion Criteria:
- Age 18-65
- At least 6 months history of constipation. Constipation defined as: a. Less than three complete spontaneous bowel movements per week and one or more of the following: i) At least 25% of stools are very hard and/or hard stools ii) Sensation of incomplete evacuation following at least 25% of bowel movements iii) Straining on at least 25% of defecations The above criteria are only applicable to spontaneous bowel movements. Patients who have no spontaneous bowel movements (bowel movements are preceded by laxative intake) are considered constipated and are eligible for this study
- For patients \>= years of age, normal colonic anatomy as documented by colonoscopy, double-contrast barium enema, or flexible sigmoidoscopy performed within the previous 5 years
- Exclusion Criteria
- Pregnancy or lactation
- Subjects unwilling to practice adequate contraception throughout the period of screening through 14 days after study termination
- Use of laxatives 3 days immediately prior to randomization (except fiber or bulking agents)
- Use of any of the following drugs within 3 days prior to randomization a) Prokinetic agents (tegaserod, domperidone, cisapride, metoclopramide, erythromycin, b) Medications containing opiates c) Antispasmodic (e.g. atropine, hyoscyamine, scopolamine, glycopyrrolate)
- Use of illegal drugs
- Regular consumption of 2 drinks of alcohol per day
- Chronic NSAIDs use
- Chronic use of H2 receptor antagonist or PPIs within 14 days prior to screening
- History of gastric or duodenal ulcer, Inflammatory bowel disease (IBD), or chronic non-ulcer dyspepsia
- Diabetes mellitus (DM) type 1
- Parkinson's disease
- Existence of any medical condition that requires chronic therapy
- Positive H. pylori serology
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01447849
Start Date
August 1 2011
End Date
November 1 2012
Last Update
June 9 2017
Active Locations (1)
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1
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905