CLINICAL TRIALS PROFILE FOR CEBRANOPADOL

Clinical Trials for Cebranopadol

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01709214 ↗	Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain	Completed	Forest Laboratories	Phase 2	The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.
NCT01709214 ↗	Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain	Completed	Grünenthal GmbH	Phase 2	The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.
NCT01709214 ↗	Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain	Completed	Tris Pharma, Inc.	Phase 2	The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.
NCT01939366 ↗	Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves	Completed	Forest Laboratories	Phase 2	The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will be undertaken to find out if the patient's general health and well-being improves under trial treatment. The concentrations of cebranopadol in the blood will be investigated to get a better understanding of how it is absorbed from the gut, distributed and broken down in the body, and eliminated from the body.
NCT01939366 ↗	Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves	Completed	Grünenthal GmbH	Phase 2	The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will be undertaken to find out if the patient's general health and well-being improves under trial treatment. The concentrations of cebranopadol in the blood will be investigated to get a better understanding of how it is absorbed from the gut, distributed and broken down in the body, and eliminated from the body.

Clinical Trial Conditions for Cebranopadol

Condition Name

Condition Name for
Intervention	Trials
Pain	3
Chronic Pain	3
Neoplasms	2
Pharmacokinetic	2

Condition MeSH

Condition MeSH for
Intervention	Trials
Chronic Pain	4
Substance-Related Disorders	1
Peripheral Nervous System Diseases	1
Diabetic Neuropathies	1

Clinical Trial Locations for Cebranopadol

Trials by Country

Trials by Country for
Location	Trials
United States	37
Denmark	3
Austria	3
Germany	3
Slovakia	2

Trials by US State

Trials by US State for
Location	Trials
Florida	3
Ohio	2
New York	2
Illinois	2
California	2

Clinical Trial Progress for Cebranopadol

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	2
Phase 1	5

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	6
Recruiting	2
Terminated	1

Clinical Trial Sponsors for Cebranopadol

Sponsor Name

Sponsor Name for
Sponsor	Trials
Tris Pharma, Inc.	9
Grünenthal GmbH	7
Forest Laboratories	4

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	20