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Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01460225
Recruitment Status : Completed
First Posted : October 26, 2011
Results First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Chronic Idiopathic Constipation
Intervention Drug: lubiprostone
Enrollment 19
Recruitment Details 19 patients entered the study; no dropouts. All patients completed the study; the entire study was contacted at Dartmouth.
Pre-assignment Details No patients were excluded.
Arm/Group Title Lubirprostone
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 19 [1]
Completed 19 [2]
Not Completed 0
[1]
January 2009.
[2]
November 2010
Arm/Group Title Lubirprostone
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
42  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
16
  84.2%
Male
3
  15.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Gastric Emptying
Hide Description gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)
Time Frame Day 1 and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prior to Treatement With Lubiprostone Post Treatment With Lubiprostone
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: percent meal retention
2 Hours after meal 0.27 [1]   (NA) 0.384 [1]   (NA)
4 Hours after meal 0.04 [2]   (NA) 0.051 [2]   (NA)
[1]
Original Data for this study have been destroyed, the study was not published and the Standard Deviation was not reported with the data in the only report available. A p= .003 was documented. This is the only measure of precision in the report.
[2]
Original Data for this study have been destroyed, the study was not published and the Standard Deviation was not reported with the data in the only report available. A p value was documented and this is the only measure of precision in the report.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prior to Treatement With Lubiprostone, Post Treatment With Lubiprostone
Comments Comparison of meal retention between pre-treatment and post treatment at 2 hours post meal
Type of Statistical Test Equivalence
Comments Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Prior to Treatement With Lubiprostone, Post Treatment With Lubiprostone
Comments Comparison of meal retention between pre-treatment and post treatment at 4 hours post meal
Type of Statistical Test Equivalence
Comments Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.
Statistical Test of Hypothesis P-Value 0.122
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All- Single Arm
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
All- Single Arm
Affected / at Risk (%)
Total   0/19 (0.00%)    
Hide Serious Adverse Events
All- Single Arm
Affected / at Risk (%) # Events
Total   0/19 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All- Single Arm
Affected / at Risk (%) # Events
Total   2/19 (10.53%)    
Gastrointestinal disorders   
nausea 1 [1]  2/19 (10.53%)  2
General disorders   
Headache *  1/19 (5.26%)  1
1
Term from vocabulary, nausea
[1]
2 patients had nausea
*
Indicates events were collected by non-systematic assessment
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. Brian Lacy
Organization: Dartmouth-Hitchcock Medical Center
Phone: 603-650-5215
EMail: brian.e.lacy@hitchcock.org
Layout table for additonal information
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01460225    
Other Study ID Numbers: 07-033L
First Submitted: July 19, 2010
First Posted: October 26, 2011
Results First Submitted: April 3, 2018
Results First Posted: July 13, 2018
Last Update Posted: July 13, 2018