Lubiprostone Effect on Gastrointestinal (GI) Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation

Chronic Idiopathic Constipation Clinical Trial

Official title:

The Effect of Lubiprostone on Transit Times Within the Alimentary Tract, Measured by Novel Smartpill Methodology in Patients With Chronic Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469819
• Other study ID #: LUB-119
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 28, 2011
• Last updated: November 20, 2015
• Start date: June 2012
• Est. completion date: February 2015

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: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if lubiprostone may change the rate of movement of food and activities in the stomach and intestines in subjects whose gastrointestinal (GI) tract is slower due to constipation.

To be able to measure the time difference in the duration of transit of the FDA approved SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure to lubiprostone.

The investigators anticipate to capture the possibility to reduce/eliminate the small intestinal bacterial overgrowth in chronically constipated patients after administration of study drug- lubiprostone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years old

• At least a 6 months history of constipation. Constipation defined as follows:

• Less than three complete spontaneous bowel movements per week and one or more of the following:

1. At least 25% of stools are very hard and/or hard stools

2. Sensation of incomplete evacuation following at least 25% of bowel movements.

3. 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 = 50 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 the 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:

• Prokinetic agents (tegaserod, domperidone, cisapride, metoclopramide, erythromycin).

• Medication containing opiates.

• Anti-spasmodic (e.g., atropine, hyoscyamine, scopolamine, glycopyrrolate).

• Use of illegal drugs

• Regular consumption of 2 drinks of alcohol per day.

• Chronic nonsteroidal antiinflammatory drugs (NSAIDs) use

• Chronic use of H2 receptor antagonist or proton pump inhibitors (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

• Chronic active diverticulosis

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• Lubiprostone
24 mcg twice a day (BID) for 2 weeks.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso	Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time reduction (hours and minutes) of gastric emptying, small, large and whole gut transits measured by SmartPill in chronically constipated patients before and after 2 weeks of therapy with lubiprostone 24mcg twice a day (BID).	The change in transit time (TT) of gastric emptying (GE), small bowel (SB), large bowel (LB), and whole gut (WG) measured by SmartPill in 15 patients with chronic constipation after taking lubiprostone 24 mcg twice a day for 2 weeks.	Measured at baseline and 2 weeks after baseline.	No
Secondary	Increase in number of bowel movements in chronically constipated patients after 2 weeks of therapy with lubiprostone 24mcg twice a day (BID).		Measured at baseline and 2 weeks after baseline	No
Secondary	Changes in time of GE, SB, LB and WG transits measured by SmartPill after 2 weeks of lubiprostone 24mcg BID in chronically constipated patients who increased stool frequency to = 7 per week vs. patients who increased stool frequency to < 7 per week.		Measured at baseline and 2 weeks after baseline.	No
Secondary	Increase in number of bowel movements per week changes gastric emptying small, large and whole gut transit times measured by SmartPill in chronically constipated patients treated for 2 weeks with lubiprostone 24mcg twice a day.		Measured at baseline and 2 weeks after baseline.	No
Secondary	Elimination of small bacterial overgrowth in chronically constipated patients treated with lubiprostone 24mcg twice a day for 2 weeks.		Measured at baseline and 2 weeks after baseline.	No