Lubiprostone and Mucus Secretion in Patients With Chronic Constipation

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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 lubrication.

Therefore, the investigators assume that administration of lubiprostone may restore this lubrication impairment by stimulation of mucus production and secretion within the gastrointestinal tract.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso
• Treatments: Lubiprostone

Criteria

Asymptomatic Volunteers:

Inclusion Criteria:

• 18-65 years of age

• Capable of and willing to give informed consent, and willing to comply with all study requirements

Exclusion Criteria:

• 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