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Trial record 21 of 80602 for:    measured

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

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ClinicalTrials.gov Identifier: NCT01469819
Recruitment Status : Completed
First Posted : November 10, 2011
Results First Posted : August 1, 2016
Last Update Posted : June 9, 2017
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Idiopathic Constipation
Intervention Drug: Lubiprostone
Enrollment 37
Recruitment Details Participants recruited from University of Kansas Medical Center, in Kansas City, KS from July 2008 to August 2009. Additional participants were recruited from Texas Tech University Health Sciences Center - El Paso, in El Paso, TX between April 2012 and November 2012.
Pre-assignment Details 37 participants recruited; 37 screened, 8 excluded. 25 of those subjects participated in small intestinal bacterial overgrowth (SIBO) testing and analysis.
Arm/Group Title All Participants
Hide Arm/Group Description Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
Period Title: Overall Study
Started 37
Completed 29
Not Completed 8
Reason Not Completed
Withdrawal by Subject             1
Did not meet inclusionary criteria             2
Could not swallow SmartPill             2
Technical malfunction of SmartPill data             3
Arm/Group Title All Participants
Hide Arm/Group Description Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants
39
(19 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
29
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
1.Primary Outcome
Title 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.
Hide Description 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 Frame Measured at baseline and 2 weeks after baseline.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
Overall Number of Participants Analyzed 29
Mean (Standard Error)
Unit of Measure: Hours
Gastric Emptying Time before treatment 7.0  (1.1)
Small Bowel Transit Time before treatment 5.9  (1.1)
Small & Large Bowel Transit Time before treatment 56.7  (8.7)
Whole Gut Transit Time before treatment 64.2  (8.5)
Gastric Emptying Time after treatment 9.3  (1.9)
Small Bowel Transit Time after treatment 4.5  (0.4)
Small & Large Bowel Transit Time after treatment 43.2  (4.6)
Whole Gut Transit Time after treatment 52.5  (4.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID).
Hide Description [Not Specified]
Time Frame Measured at baseline and 2 weeks after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients aster all inclusionary criteria were met.
Overall Number of Participants Analyzed 29
Mean (Standard Error)
Unit of Measure: number per week
Bowel Movements before treatment 1.9  (0.1)
Bowel Movements after treatment 4.6  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients.
Hide Description 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.
Time Frame Measured at baseline and 2 weeks after baseline.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Responders Non-Responders
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Subgroup of patients who clinically responded to lubiprostone defined as ≥ 2 times increase in their weekly bowel movement.
Subgroup of patients who had <2 times increase in their weekly bowel movement.
Overall Number of Participants Analyzed 16 13
Mean (Standard Error)
Unit of Measure: Hours
Gastric Emptying Time before treatment 9.6  (1.5) 3.9  (1.2)
Small Bowel Transit Time before treatment 7.2  (2.1) 4.5  (0.3)
Small & Large Bowel Transit Time before treatment 45.9  (6.8) 70.1  (17.3)
Whole Gut Transit Time before treatment 55.5  (6.3) 75.0  (17.3)
Gastric Emptying Time after treatment 11.6  (2.9) 6.4  (2.1)
Small Bowel Transit Time after treatment 4.4  (0.6) 4.5  (0.5)
Small & Large Bowel Transit Time after treatment 32.0  (4.3) 57.0  (7.2)
Whole Gut Transit Time after treatment 43.7  (4.6) 63.4  (8.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Responders, Non-Responders
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Measured at baseline and 2 weeks after baseline.
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Bowel Movements per week
Arm/Group Title Responders Non-Responders
Hide Arm/Group Description:
Subgroup of patients who clinically responded to lubiprostone defined as > 2 times increase in their weekly bowel movement compared to baseline.
Subgroup of patients who had <2 times increase in their weekly bowel movement
Overall Number of Participants Analyzed 16 13
Mean (Standard Error)
Unit of Measure: number per week
Bowel Movements before treatment 1.8  (0.1) 2.1  (0.2)
Bowel Movements after treatment 6.0  (0.5) 3.0  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Responders, Non-Responders
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks.
Hide Description [Not Specified]
Time Frame Measured at baseline and 2 weeks after baseline.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SIBO (+)
Hide Arm/Group Description:
Twenty-five patients were tested for SIBO before treatment with lubiprostone and 17 (68.0%) were SIBO (+) at baseline.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
SIBO (+) participants before treatment 17
SIBO (+) participants after treatment 10
SIBO (+)→SIBO (-) participants after treatments 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%) # Events
Total   6/29 (20.69%)    
Gastrointestinal disorders   
Nausea * [1]  6/29 (20.69%)  6
*
Indicates events were collected by non-systematic assessment
[1]
6 patients experienced nausea after the drug administration of lubiprostone. Only 3 of these patients were diagnosed with prolonged gastric emptying time. None of these patients required any clinical attention or discontinuation of the study drug.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Irene Sarosiek
Organization: Texas Tech University Health Sciences Center El Paso
Phone: (915)215-5254
EMail: irene.sarosiek@ttuhsc.edu
Layout table for additonal information
Responsible Party: Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT01469819     History of Changes
Other Study ID Numbers: LUB-119
First Submitted: October 28, 2011
First Posted: November 10, 2011
Results First Submitted: May 9, 2016
Results First Posted: August 1, 2016
Last Update Posted: June 9, 2017