NCT01447849

Lubiprostone and Mucus Secretion in Patients With Chronic Constipation

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Texas Tech University Health Sciences Center, El Paso · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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 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).

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	lubiprostone	24mcg twice a day (BID) 1 week
DRUG	placebo	Placebo pills twice a day for one week.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-10-06
• Last updated: 2017-06-09
• Results posted: 2013-09-23

Locations

1 site across 1 country: United States