Effects of Lubiprostone on Gastric Function in Patients W... | NCT01460225

Name	Class
Takeda Pharmaceuticals North America, Inc.	INDUSTRY

Effects of Lubiprostone on Gastric Function in Patients W... | NCT01460225 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Treatment	Experimental	24 micrograms of lubiprostone twice daily for one week.	Drug: lubiprostone

Name	Type	Description	Arm Group Labels	Other Names
lubiprostone	Drug	24 micrograms twice daily for 1 week	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastric Emptying	gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)	Day 1 and Day 7

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Dartmouth-Hitchcock Medical Center		Lebanon	New Hampshire	03756	United States

ID	Title	Description
FG000	Lubirprostone

Baseline Characteristics Module

ID	Title	Description
BG000	Lubirprostone

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Gastric Emptying

gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)

Posted

Mean

Standard Deviation

percent meal retention

Day 1 and Day 7

ID	Title	Description
OG000	Prior to Treatement With Lubiprostone
OG001	Post Treatment With Lubiprostone

Units	Counts
Participants

Adverse Events Module

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	All- Single Arm		0	19

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
nausea	Gastrointestinal disorders	nausea		2 patients had nausea

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Brian Lacy	Dartmouth-Hitchcock Medical Center	603-650-5215		brian.e.lacy@hitchcock.org

Condition Browse Module

ID	Term
D003248	Constipation

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Intervention Browse Module

ID	Term
D000068238	Lubiprostone

ID	Term
D000527	Alprostadil
D005229	Fatty Acids, Monounsaturated
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids

Title

Denominators

Categories

2 Hours after meal

Title

Measurements

OG0000.27± NAOriginal 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.
OG0010.384± NAOriginal 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.

4 Hours after meal

Title

Measurements

OG0000.04± NAOriginal 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.
OG0010.051± NAOriginal 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.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Comparison of meal retention between pre-treatment and post treatment at 2 hours post meal	t-test, 2 sided		0.003														Equivalence	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.
OG000 OG001	Comparison of meal retention between pre-treatment and post treatment at 4 hours post meal	t-test, 2 sided		0.122														Equivalence	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.