NCT01469819

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 1, 2016

Completed
Last Updated

June 9, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

October 28, 2011

Results QC Date

May 9, 2016

Last Update Submit

May 5, 2017

Conditions

Chronic Idiopathic Constipation

Keywords

chronic constipationconstipationidiopathic constipationSmartPillWireless Motility Capsulelubiprostone (Amitiza)small intestinal bacterial overgrowth

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    Measured at baseline and 2 weeks after baseline.

Secondary Outcomes (4)

  • Changes 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

  • Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients.

    Measured at baseline and 2 weeks after baseline.

  • 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.

    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.

    Measured at baseline and 2 weeks after baseline.

Study Arms (1)

Lubiprostone

EXPERIMENTAL

Lubiprostone 24 mcg by mouth twice a day (BID) for 2 weeks.

Drug: Lubiprostone

Interventions

LubiprostoneDRUG

24 mcg twice a day (BID) for 2 weeks.

Also known as: Amitiza
Lubiprostone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • At least 25% of stools are very hard and/or hard stools
  • Sensation of incomplete evacuation following at least 25% of bowel movements.
  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Related Publications (1)

  • Sarosiek I, Bashashati M, Alvarez A, Hall M, Shankar N, Gomez Y, McCallum RW, Sarosiek J. Lubiprostone Accelerates Intestinal Transit and Alleviates Small Intestinal Bacterial Overgrowth in Patients With Chronic Constipation. Am J Med Sci. 2016 Sep;352(3):231-8. doi: 10.1016/j.amjms.2016.05.012. Epub 2016 May 24.

    PMID: 27650225DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlprostadilFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Results Point of Contact

Title
Dr. Irene Sarosiek
Organization
Texas Tech University Health Sciences Center El Paso
irene.sarosiek@ttuhsc.edu
(915)215-5254

Study Officials

  • Irene Sarosiek, MD

    Texas Tech University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2011

First Posted

November 10, 2011

Study Start

June 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 9, 2017

Results First Posted

August 1, 2016

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)