CLINICAL TRIALS PROFILE FOR ALVIMOPAN

All Clinical Trials for alvimopan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00101998 ↗	Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication	Completed	GlaxoSmithKline	Phase 2	2003-10-01	A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.
NCT00101998 ↗	Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication	Completed	Cubist Pharmaceuticals LLC	Phase 2	2003-10-01	A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.
NCT00135577 ↗	Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects	Completed	GlaxoSmithKline	Phase 2	2004-09-01	Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain. Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.
NCT00135577 ↗	Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects	Completed	Cubist Pharmaceuticals LLC	Phase 2	2004-09-01	Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain. Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.
NCT00205842 ↗	Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus	Completed	GlaxoSmithKline	Phase 3	2004-06-01	Patients undergoing major abdominal surgery are at highest risk for developing Postoperative Ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function in patients having partial small or large bowel resections.
NCT00205842 ↗	Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus	Completed	Cubist Pharmaceuticals LLC	Phase 3	2004-06-01	Patients undergoing major abdominal surgery are at highest risk for developing Postoperative Ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function in patients having partial small or large bowel resections.
NCT00241722 ↗	Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain	Completed	GlaxoSmithKline	Phase 3	2005-08-01	Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.

Clinical Trial Conditions for alvimopan

Condition Name

Condition Name for alvimopan
Intervention	Trials
Ileus	10
Constipation	6
Bowel Dysfunction	6
Postoperative Ileus	3

Condition MeSH

Condition MeSH for alvimopan
Intervention	Trials
Ileus	14
Intestinal Diseases	10
Constipation	7
Gastrointestinal Diseases	5

Clinical Trial Locations for alvimopan

Trials by Country

Trials by Country for alvimopan
Location	Trials
United States	170
Canada	30
United Kingdom	16
Australia	14
Germany	11

Trials by US State

Trials by US State for alvimopan
Location	Trials
Pennsylvania	7
Ohio	7
North Carolina	7
California	7
Oregon	6

Clinical Trial Progress for alvimopan

Clinical Trial Phase

Clinical Trial Phase for alvimopan
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	12
Phase 2	7

Clinical Trial Status

Clinical Trial Status for alvimopan
Clinical Trial Phase	Trials
Completed	21
Recruiting	4
Terminated	4

Clinical Trial Sponsors for alvimopan

Sponsor Name

Sponsor Name for alvimopan
Sponsor	Trials
Cubist Pharmaceuticals LLC	15
GlaxoSmithKline	11
Merck Sharp & Dohme Corp.	6

Sponsor Type

Sponsor Type for alvimopan
Sponsor	Trials
Industry	32
Other	22