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

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier:
NCT01469819
First received: October 28, 2011
Last updated: May 5, 2017
Last verified: May 2017
October 28, 2011
May 5, 2017
June 2012
February 2015   (Final data collection date for primary outcome measure)
Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. [ Time Frame: Measured at baseline and 2 weeks after baseline. ]
The change in transit time (TT), in hours and minutes, of gastric emptying (GE), small bowel (SB), large bowel (LB) and whole gut (WG) measured by SmartPill in 29 patients with chronic constipation after taking lubiprostone 24 micrograms twice a day (BID) for 2 weeks.
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. ]
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.
Complete list of historical versions of study NCT01469819 on ClinicalTrials.gov Archive Site
  • Changes 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 ]
  • Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients. [ Time Frame: Measured at baseline and 2 weeks after baseline. ]
    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 ≥ 2 times increase per week vs. patients who increased stool frequency < 2 times increase per week.
  • Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG 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. ]
  • Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks. [ Time Frame: Measured at baseline and 2 weeks after baseline. ]
  • 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 ]
  • 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. ]
  • 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. ]
  • 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. ]
Not Provided
Not Provided
 
Lubiprostone Effect on Gastrointestinal 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.

Lubiprostone is an effective treatment for chronic constipation. The mechanism of action of lubiprostone is through increasing fluid and mucus secretion and improving lubrication of the intestinal lumen. The effects of lubiprostone on gastrointestinal (GI) transit and small bacterial overgrowth (SIBO) have not been sufficiently explored.

The current study was designed to investigate whether: (a) lubiprostone alters GI transit and (b) affects SIBO in constipated patients.

Twenty nine female patients (mean age of 39 year: range 19-64) with chronic constipation received 2 weeks of lubiprostone (24 mcg b.i.d., P.O.). Stool consistency based on Bristol stool scale and the frequency of bowel movements were recorded. Gastric emptying time (GET), small bowel transit time (SBTT), colon transit time (CTT), combined small & large bowel transit time (SLBTT) and whole gut transit time (WGT) were measured using wireless motility capsule. Small bacterial overgrowth (SIBO) status was assessed by the lactulose breath test.

Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: No masking
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.
 
Completed
37
February 2015
February 2015   (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01469819
LUB-119
No
Not Provided
No
Not Provided
Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso
Texas Tech University Health Sciences Center, El Paso
Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Irene Sarosiek, MD Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center, El Paso
May 2017

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