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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

October 28, 2011
April 11, 2014
June 2012
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01469819 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Lubiprostone Effect on Gastrointestinal (GI) Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation
The Effect of Lubiprostone on Transit Times Within the Alimentary Tract, Measured by Novel Smartpill Methodology in Patients With Chronic Constipation

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Idiopathic Constipation
Drug: Lubiprostone
24 mcg twice a day (BID) for 2 weeks.
Other Name: Amitiza
Experimental: Lubiprostone
Lubiprostone 24 mcg by mouth twice a day (BID) for 2 weeks.
Intervention: Drug: Lubiprostone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01469819
LUB-119
No
Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Irene Sarosiek, MD Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP