CLINICAL TRIALS PROFILE FOR AMITIZA

All Clinical Trials for Amitiza

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00611442 ↗	Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy	Completed	Takeda	N/A	2007-10-01	The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.
NCT00611442 ↗	Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy	Completed	Brooke Army Medical Center	N/A	2007-10-01	The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.
NCT00620061 ↗	Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone	Completed	Takeda	Phase 3	2007-12-01	The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.
NCT00620061 ↗	Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone	Completed	Sucampo Pharma Americas, LLC	Phase 3	2007-12-01	The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.
NCT00620061 ↗	Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone	Completed	Sucampo Pharmaceuticals, Inc.	Phase 3	2007-12-01	The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.
NCT00645801 ↗	Amitiza® Plus GoLYTELY® Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation	Completed	Takeda Pharmaceuticals North America, Inc.	Phase 4	2008-03-01	The primary objective is to compare the effectiveness and tolerance of Amitiza® (lubiprostone) plus GoLYTELY® (polyethylene glycol-electrolyte solution) versus placebo and GoLYTELY ® (polyethylene glycol-electrolyte solution) as a bowel cleansing preparation for colonoscopy.
NCT00645801 ↗	Amitiza® Plus GoLYTELY® Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation	Completed	Henry Ford Health System	Phase 4	2008-03-01	The primary objective is to compare the effectiveness and tolerance of Amitiza® (lubiprostone) plus GoLYTELY® (polyethylene glycol-electrolyte solution) versus placebo and GoLYTELY ® (polyethylene glycol-electrolyte solution) as a bowel cleansing preparation for colonoscopy.

Clinical Trial Conditions for Amitiza

Condition Name

Condition Name for Amitiza
Intervention	Trials
Constipation	8
Chronic Idiopathic Constipation	5
Irritable Bowel Syndrome	3
Constipation - Functional	2

Condition MeSH

Condition MeSH for Amitiza
Intervention	Trials
Constipation	17
Irritable Bowel Syndrome	4
Opioid-Induced Constipation	3
Syndrome	2

Clinical Trial Locations for Amitiza

Trials by Country

Trials by Country for Amitiza
Location	Trials
United States	214
United Kingdom	10
Mexico	8
Canada	5
Korea, Republic of	4

Trials by US State

Trials by US State for Amitiza
Location	Trials
Texas	14
Alabama	9
Georgia	8
Florida	8
California	8

Clinical Trial Progress for Amitiza

Clinical Trial Phase

Clinical Trial Phase for Amitiza
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	10
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Amitiza
Clinical Trial Phase	Trials
Completed	25
Terminated	3

Clinical Trial Sponsors for Amitiza

Sponsor Name

Sponsor Name for Amitiza
Sponsor	Trials
Takeda	15
Sucampo Pharma Americas, LLC	10
Sucampo AG	8

Sponsor Type

Sponsor Type for Amitiza
Sponsor	Trials
Industry	49
Other	18
U.S. Fed	2