Lubiprostone and Mucus Secretion in Patients With Chronic Constipation

Constipation Clinical Trial

Official title:

The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447849
• Other study ID #: MSA-LUB-125
• Secondary ID: MSA-NC-LUB-125
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 14, 2011
• Last updated: November 10, 2015
• Start date: August 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2015
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 conditions (primary outcome).

Specific Aim 2. To explore 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 during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (primary outcome).

Specific Aim 3. To address the influence of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucin production, the major component of mucus, in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal conditions (primary outcome).

Specific Aim 4. To test the influence of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucin production, the major component of mucus, in 20 asymptomatic volunteers and 20 patients with chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (primary outcome).

Specific Aim 5. To explore the impact of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on viscoelasticity of gastric mucus in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal conditions (secondary outcome).

Specific Aim 6. To address the impact of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on viscoelasticity of gastric mucus in 20 asymptomatic volunteers and 20 patients with chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (secondary outcome).

Other known NCT identifiers

• NCT00595036

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• lubiprostone
24mcg twice a day (BID) 1 week
• Placebo
Placebo pills twice a day for one week.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.	The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).	Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between.	No
Secondary	Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.	The viscoelasticity of gastric mucus(centipoises) was measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).	Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between.	No