Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

McKinsey
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Express Scripts
Baxter
Colorcon

Last Updated: October 16, 2019

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CLINICAL TRIALS PROFILE FOR ENTEREG

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Clinical Trials for Entereg

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00256932 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 (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
NCT00256932 Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain Completed Cubist Pharmaceuticals LLC 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 (1:1:1) to one 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
NCT00259922 Alvimopan For The 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 (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
NCT00259922 Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain Completed Cubist Pharmaceuticals LLC 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 (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
NCT00708201 A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy Completed Cubist Pharmaceuticals LLC Phase 4 2009-03-01 This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are: - to evaluate the effect of alvimopan on hospital length of stay - to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities - to evaluate the overall and cardiovascular safety of alvimopan
NCT01143259 Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use Completed Cubist Pharmaceuticals LLC N/A 2010-05-01 The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.
NCT01143259 Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use Completed Intermountain Health Care, Inc. N/A 2010-05-01 The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Entereg

Condition Name

Condition Name for Entereg
Intervention Trials
Ileus 5
Constipation 3
Colorectal Surgery 2
Bowel Dysfunction 2
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Condition MeSH

Condition MeSH for Entereg
Intervention Trials
Ileus 6
Constipation 3
Intestinal Diseases 2
Gastrointestinal Diseases 2
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Clinical Trial Locations for Entereg

Trials by Country

Trials by Country for Entereg
Location Trials
United States 92
Canada 12
Germany 8
United Kingdom 7
Australia 5
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Trials by US State

Trials by US State for Entereg
Location Trials
California 4
North Carolina 4
Ohio 4
Wisconsin 3
Oregon 3
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Clinical Trial Progress for Entereg

Clinical Trial Phase

Clinical Trial Phase for Entereg
Clinical Trial Phase Trials
Phase 4 4
Phase 3 5
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Entereg
Clinical Trial Phase Trials
Completed 7
Not yet recruiting 5
Recruiting 2
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Clinical Trial Sponsors for Entereg

Sponsor Name

Sponsor Name for Entereg
Sponsor Trials
Cubist Pharmaceuticals LLC 7
Merck Sharp & Dohme Corp. 4
GlaxoSmithKline 3
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Sponsor Type

Sponsor Type for Entereg
Sponsor Trials
Industry 14
Other 13
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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Colorcon
Merck
Harvard Business School
McKesson

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