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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01469819
First received: October 28, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Chronic Idiopathic Constipation
Drug: Lubiprostone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Lubiprostone on Transit Times Within the Alimentary Tract, Measured by Novel Smartpill Methodology in Patients With Chronic Constipation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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). [ Time Frame: Measured at baseline and 2 weeks after baseline. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Increase in number of bowel movements in chronically constipated patients after 2 weeks of therapy with lubiprostone 24mcg twice a day (BID). [ Time Frame: Measured at baseline and 2 weeks after baseline ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Measured at baseline and 2 weeks after baseline. ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Measured at baseline and 2 weeks after baseline. ] [ Designated as safety issue: No ]
  • Elimination of small bacterial overgrowth in chronically constipated patients treated with lubiprostone 24mcg twice a day for 2 weeks. [ Time Frame: Measured at baseline and 2 weeks after baseline. ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lubiprostone
Lubiprostone 24 mcg by mouth twice a day (BID) for 2 weeks.
Drug: Lubiprostone
24 mcg twice a day (BID) for 2 weeks.
Other Name: Amitiza

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469819

Locations
United States, Texas
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Irene Sarosiek, MD Texas Tech University Health Sciences Center
  More Information

No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01469819     History of Changes
Other Study ID Numbers: LUB-119
Study First Received: October 28, 2011
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
chronic constipation
constipation
idiopathic constipation
SmartPill
Wireless Motility Capsule
lubiprostone (Amitiza)
small intestinal bacterial overgrowth

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

ClinicalTrials.gov processed this record on October 21, 2014