CLINICAL TRIALS PROFILE FOR PREGABALIN

505(b)(2) Clinical Trials for Pregabalin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00209495 ↗	Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients	Completed	Glostrup University Hospital, Copenhagen	Phase 4	2005-06-01	Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.
New Combination	NCT00235261 ↗	Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations	Completed	Glostrup University Hospital, Copenhagen	Phase 4	2005-10-01	Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine and improve the patients pain score after operation.
New Combination	NCT00378547 ↗	Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Having a Tonsillectomy	Terminated	Glostrup University Hospital, Copenhagen	Phase 4	2006-01-01	Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative period, and another often used analgetic, morphine, causes nausea and vomiting. The researchers therefore will investigate new combinations of postoperative analgesics in hopes of improving pain and the need for opioids during the postoperative period.
New Formulation	NCT01638273 ↗	PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects	Completed	GL Pharm Tech Corporation	Phase 1	2014-02-01	The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
New Formulation	NCT02326987 ↗	A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS-NF1 Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects	Completed	GL Pharm Tech Corporation	Phase 1	2013-10-01	The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".

All Clinical Trials for Pregabalin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00035412 ↗	St. John's Wort Versus Placebo in Social Phobia	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 2	2001-12-01	The purpose of this study is to determine the effectiveness of St. John's Wort as compared to placebo (an inactive substance) in the treatment of outpatients with social phobia.
NCT00141219 ↗	Pregabalin Peripheral Neuropathic Pain Study	Completed	Pfizer	Phase 3	2005-12-01	To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.
NCT00141219 ↗	Pregabalin Peripheral Neuropathic Pain Study	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 3	2005-12-01	To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.
NCT00141245 ↗	To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.	Completed	Pfizer	Phase 3	1998-10-01	To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.
NCT00141258 ↗	Pregabalin Epilepsy Add-On Trial	Completed	Pfizer	Phase 3	2005-10-01	To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures
NCT00141258 ↗	Pregabalin Epilepsy Add-On Trial	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 3	2005-10-01	To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures
NCT00141336 ↗	To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.	Completed	Pfizer	Phase 3	1999-11-01	To evaluate the long-term safety and tolerability of pregabalin in patients with partial seizures.

Clinical Trial Conditions for Pregabalin

Condition Name

Condition Name for Pregabalin
Intervention	Trials
Pain	34
Healthy	33
Fibromyalgia	33
Neuropathic Pain	28

Condition MeSH

Condition MeSH for Pregabalin
Intervention	Trials
Neuralgia	98
Pain, Postoperative	72
Diabetic Neuropathies	49
Peripheral Nervous System Diseases	43

Clinical Trial Locations for Pregabalin

Trials by Country

Trials by Country for Pregabalin
Location	Trials
Japan	129
Canada	126
United Kingdom	95
India	90
China	83

Trials by US State

Trials by US State for Pregabalin
Location	Trials
Florida	73
California	73
Texas	67
New York	62
Ohio	58

Clinical Trial Progress for Pregabalin

Clinical Trial Phase

Clinical Trial Phase for Pregabalin
Clinical Trial Phase	Trials
Phase 4	154
Phase 3	129
Phase 2/Phase 3	19

Clinical Trial Status

Clinical Trial Status for Pregabalin
Clinical Trial Phase	Trials
Completed	314
Recruiting	50
Terminated	49

Clinical Trial Sponsors for Pregabalin

Sponsor Name

Sponsor Name for Pregabalin
Sponsor	Trials
Pfizer	160
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	107
Yuhan Corporation	7

Sponsor Type

Sponsor Type for Pregabalin
Sponsor	Trials
Other	402
Industry	373
NIH	17