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Lubiprostone and Mucus Secretion in Patients With Chronic Constipation

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ClinicalTrials.gov Identifier: NCT01447849
Recruitment Status : Completed
First Posted : October 6, 2011
Results First Posted : September 23, 2013
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Jerzy Sarosiek, Texas Tech University Health Sciences Center, El Paso

Study Description
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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 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 or disease Intervention/treatment Phase
Constipation Drug: lubiprostone Drug: placebo Phase 2 Phase 3

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation
Study Start Date : August 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lubiprostone 24 mcg Twice a day
Both controls and patients with chronic constipation will receive 1 week of therapy with lubiprostone and one week of placebo.
 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
Placebo pills twice a day for one week.


Outcome Measures
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Primary Outcome Measures :
  1. Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. [ Time Frame: Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between. ]
    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 :
  1. Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation. [ Time Frame: Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between. ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447849


Locations
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United States, Texas
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
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Principal Investigator: Jerzy Sarosiek, MD, PhD Texas Tech University Health Sciences Center
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jerzy Sarosiek, Professor of Medicine, Associate Chairman for Research, Internal Medicine Department, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT01447849    
Obsolete Identifiers: NCT00595036
Other Study ID Numbers: MSA-LUB-125
MSA-NC-LUB-125 ( Other Grant/Funding Number: Takeda Pharmaceuticals )
First Posted: October 6, 2011    Key Record Dates
Results First Posted: September 23, 2013
Last Update Posted: June 9, 2017
Last Verified: November 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jerzy Sarosiek, Texas Tech University Health Sciences Center, El Paso:
Chronic Constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Lubiprostone
 Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action