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Lubiprostone and Mucus Secretion in Patients With Chronic Constipation

Primary Purpose

Constipation

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

lubiprostone

placebo

About this trial

This is an interventional treatment trial for Constipation focused on measuring Chronic Constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lubiprostone 24 mcg Twice a day

Placebo

Arm Description

Both controls and patients with chronic constipation will receive 1 week of therapy with lubiprostone and one week of placebo.

Both controls and patients with chronic constipation will receive placebo pills twice daily for one week in cross over design

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT01447849

First Posted

September 14, 2011

Last Updated

May 5, 2017

Sponsor

Texas Tech University Health Sciences Center, El Paso

1. Study Identification

Unique Protocol Identification Number

NCT01447849

Brief Title

Lubiprostone and Mucus Secretion in Patients With Chronic Constipation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas Tech University Health Sciences Center, El Paso

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

Keywords

Chronic Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lubiprostone 24 mcg Twice a day

Arm Type

Active Comparator

Arm Description

Both controls and patients with chronic constipation will receive 1 week of therapy with lubiprostone and one week of placebo.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Both controls and patients with chronic constipation will receive placebo pills twice daily for one week in cross over design

Intervention Type

Drug

Intervention Name(s)

lubiprostone

Other Intervention Name(s)

Amitiza

Intervention Description

24mcg twice a day (BID) 1 week

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo pills twice a day for one week.

Primary Outcome Measure Information:

Title

Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.

Description

Time Frame

Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between.

Secondary Outcome Measure Information:

Title

Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.

Description

Time Frame

Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerzy Sarosiek, MD, PhD

Organizational Affiliation

Texas Tech University Health Sciences Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas Tech University Health Sciences Center

City

El Paso

State/Province

Texas

ZIP/Postal Code

79905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Lubiprostone and Mucus Secretion in Patients With Chronic Constipation

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