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

This study is currently recruiting participants.
Verified October 2011 by Texas Tech University Health Sciences Center
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01447849
First received: September 14, 2011
Last updated: October 4, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Constipation
 Drug: Lubiprostone
Drug: Placebo Comparator
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Increase in volume and concentration of mucus and mucin secretion per millileter of solution in controls and patients with chronic constipation. [ Time Frame: Measured at baseline and 1 week after baseline ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Increase in amount of viscoelasticity of gastric secretion in controls and patients with chronic constipation. [ Time Frame: Measured at baseline and 1 week after baseline ] [ Designated as safety issue: No ]
    The viscoelasticity of gastric mucus(Ctpois) 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).


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lubiprostone 24mcg twice a day (BID)
Both controls and patients with chronic constipation will receive 1 week of therapy with lubiprostone.
 Drug: Lubiprostone
24mcg twice a day (BID) 1 week
Other Name: Amitiza
Placebo Comparator: Placebo
Both controls and patients with chronic constipation will receive placebo pills twice daily for one week in cross over design
 Drug: Placebo Comparator
Placebo pills twice a day for one week.

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 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 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 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 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 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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447849

Contacts
Contact: Jerzy Sarosiek, MD, PhD 915-545-6626 ext 297 jerzy.sarosiek@ttuhsc.edu
Contact: Sean Connery sean.connery@ttuhsc.edu

Locations
United States, Texas
Texas Tech University Health Sciences Center Recruiting
El Paso, Texas, United States, 79905
Principal Investigator: Jerzy Sarosiek, MD, PhD            
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Jerzy Sarosiek, MD, PhD Texas Tech University Health Sciences Center
  More Information

No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01447849     History of Changes
Obsolete Identifiers: NCT00595036
Other Study ID Numbers: 07-022L
Study First Received: September 14, 2011
Last Updated: October 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Texas Tech University Health Sciences Center:
Chronic Constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013