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Last Updated: July 28, 2021

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CLINICAL TRIALS PROFILE FOR PREGABALIN

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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)".
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
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
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.
NCT00141362 ↗ Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Chronic Neuropathic Pain. Completed Pfizer Phase 3 2001-10-01 Evaluate long-term safety and efficacy of pregabalin in patients with chronic neuropathic pain.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Pregabalin

Condition Name

Condition Name for Pregabalin
Intervention Trials
Fibromyalgia 32
Pain 31
Healthy 31
Neuropathic Pain 23
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Condition MeSH

Condition MeSH for Pregabalin
Intervention Trials
Neuralgia 85
Pain, Postoperative 60
Diabetic Neuropathies 40
Peripheral Nervous System Diseases 37
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Clinical Trial Locations for Pregabalin

Trials by Country

Trials by Country for Pregabalin
Location Trials
Japan 129
Canada 115
India 84
United Kingdom 77
China 76
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Trials by US State

Trials by US State for Pregabalin
Location Trials
California 65
Florida 64
Texas 59
New York 54
Ohio 53
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Clinical Trial Progress for Pregabalin

Clinical Trial Phase

Clinical Trial Phase for Pregabalin
Clinical Trial Phase Trials
Phase 4 137
Phase 3 122
Phase 2/Phase 3 14
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Clinical Trial Status

Clinical Trial Status for Pregabalin
Clinical Trial Phase Trials
Completed 236
Recruiting 75
Not yet recruiting 57
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Clinical Trial Sponsors for Pregabalin

Sponsor Name

Sponsor Name for Pregabalin
Sponsor Trials
Pfizer 158
Tel-Aviv Sourasky Medical Center 5
GL Pharm Tech Corporation 5
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Sponsor Type

Sponsor Type for Pregabalin
Sponsor Trials
Other 330
Industry 229
NIH 15
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