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| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00624780 |
Purpose
The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).
| Condition | Intervention | Phase |
|---|---|---|
|
Generalized Anxiety Disorder |
Drug: Pregabalin Drug: Lorazepam Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder |
| Estimated Enrollment: | 600 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Pregabalin
Pregabalin 150-300 mg given twice a day
|
| 2: Active Comparator |
Drug: Lorazepam
Lorazepam 3-4 mg given twice a day
|
| 3: Experimental |
Drug: Pregabalin
Pregabalin 450-600 mg given twice a day
|
| 4: Placebo Comparator |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of GAD. HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline. Needs pharmacological treatment.
Exclusion Criteria:
Current or past diagnosis of any other DSM IV Axis I disorders. A history of failed treatment with a benzodiazepine. Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder.
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
| Argentina | |
| Pfizer Investigational Site | Not yet recruiting |
| Buenos Aires, Argentina, C1405BOA | |
| Pfizer Investigational Site | Not yet recruiting |
| Buenos Aires, Argentina, C1115AAJ | |
| Argentina, Buenos Aires | |
| Pfizer Investigational Site | Not yet recruiting |
| La Plata, Buenos Aires, Argentina, B1904ADM | |
| Argentina, Prov. de Buenos Aires | |
| Pfizer Investigational Site | Not yet recruiting |
| Lanus, Prov. de Buenos Aires, Argentina, B1824IBR | |
| Austria | |
| Pfizer Investigational Site | Not yet recruiting |
| Wien, Austria, A-1090 | |
| Pfizer Investigational Site | Not yet recruiting |
| Wien, Austria, A-1010 | |
| Czech Republic | |
| Pfizer Investigational Site | Not yet recruiting |
| Strakonice, Czech Republic, 386 01 | |
| Pfizer Investigational Site | Not yet recruiting |
| Praha 6, Czech Republic, 163 00 | |
| Pfizer Investigational Site | Not yet recruiting |
| Brno, Czech Republic, 602 00 | |
| Pfizer Investigational Site | Not yet recruiting |
| Litomerice, Czech Republic, 412 01 | |
| Pfizer Investigational Site | Not yet recruiting |
| Melnik, Czech Republic, 276 01 | |
| Pfizer Investigational Site | Not yet recruiting |
| Praha 10- Strasnice, Czech Republic, 10000 | |
| Pfizer Investigational Site | Not yet recruiting |
| Ceske Budejovice, Czech Republic, 370 87 | |
| Czech Republic, 387 42 | |
| Pfizer Investigational Site | Not yet recruiting |
| Lnare, 387 42, Czech Republic | |
| Finland | |
| Pfizer Investigational Site | Recruiting |
| Turku, Finland, 20100 | |
| Pfizer Investigational Site | Recruiting |
| Kuopio, Finland, 70110 | |
| Pfizer Investigational Site | Not yet recruiting |
| HUS, Finland, 00029 | |
| Pfizer Investigational Site | Recruiting |
| Seinajoki, Finland, 60100 | |
| India, Karnataka | |
| Pfizer Investigational Site | Not yet recruiting |
| Mangalore, Karnataka, India, 575001 | |
| India, Maharashtra | |
| Pfizer Investigational Site | Not yet recruiting |
| Pune, Maharashtra, India, 411 030 | |
| Lithuania | |
| Pfizer Investigational Site | Not yet recruiting |
| Kaunas, Lithuania, 50185 | |
| Pfizer Investigational Site | Not yet recruiting |
| Kaunas, Lithuania, 50425 | |
| Pfizer Investigational Site | Not yet recruiting |
| Klaipeda, Lithuania, 94231 | |
| Pfizer Investigational Site | Not yet recruiting |
| Vilnius, Lithuania, 09112 | |
| Spain | |
| Pfizer Investigational Site | Not yet recruiting |
| ZAMORA, Spain, 49021 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trials Disclosure Group ) |
| Study ID Numbers: | A0081147 |
| Study First Received: | February 15, 2008 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00624780 History of Changes |
| Health Authority: | Finland: National Agency of Medicines (Lääkelaitos) |
|
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Pregabalin Central Nervous System Depressants Antiemetics Lorazepam |
Anxiety Disorders Mental Disorders Hypnotics and Sedatives Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Anticonvulsants |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Antiemetics Lorazepam Pathologic Processes Sensory System Agents Mental Disorders Therapeutic Uses Hypnotics and Sedatives Analgesics |
Disease Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Pregabalin Pharmacologic Actions Anxiety Disorders Autonomic Agents GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |
