Trial record 1 of 1 for:
A0081121
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia
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| ClinicalTrials.gov Identifier: NCT00424372 |
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Recruitment Status :
Completed
First Posted : January 19, 2007
Results First Posted : September 28, 2009
Last Update Posted : November 11, 2009
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Sponsor:
Pfizer
Information provided by:
Pfizer
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Brief Summary:
To evaluate the safety of the long-term use of pregabalin.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neuralgia, Postherpetic | Drug: pregabalin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 126 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In The Treatment Of Postherpetic Neuralgia |
| Study Start Date : | January 2007 |
| Actual Primary Completion Date : | August 2008 |
| Actual Study Completion Date : | August 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Shingles
Drug Information available for:
Pregabalin
| Arm | Intervention/treatment |
|---|---|
| Experimental: pregabalin |
Drug: pregabalin
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks |
Primary Outcome Measures :
- Summary of Adverse Events [ Time Frame: 52 weeks ]
Secondary Outcome Measures :
- Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score [ Time Frame: 52 weeks ]
- Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score [ Time Frame: 52 weeks ]
- Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score [ Time Frame: 52 weeks ]
- Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity [ Time Frame: 52 weeks ]
- Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale [ Time Frame: 52 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120.
- Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.
Exclusion Criteria:
- Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication.
- Patients exhibiting treatment non-compliance in the preceding study (A0081120)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424372
Locations
| Japan | |
| Pfizer Investigational Site | |
| Nagoya, Aichi, Japan | |
| Pfizer Investigational Site | |
| Urayasu, Chiba, Japan | |
| Pfizer Investigational Site | |
| Kasuya-gun, Fukuoka, Japan | |
| Pfizer Investigational Site | |
| Maebashi, Gunma, Japan | |
| Pfizer Investigational Site | |
| Takasaki, Gunma, Japan | |
| Pfizer Investigational Site | |
| Asahikawa, Hokkaido, Japan | |
| Pfizer Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| Pfizer Investigational Site | |
| Akashi, Hyogo, Japan | |
| Pfizer Investigational Site | |
| Amagasaki, Hyogo, Japan | |
| Pfizer Investigational Site | |
| Himeji, Hyogo, Japan | |
| Pfizer Investigational Site | |
| Kobe, Hyogo, Japan | |
| Pfizer Investigational Site | |
| Sagamihara, Kanagawa, Japan | |
| Pfizer Investigational Site | |
| Yokohama, Kanagawa, Japan | |
| Pfizer Investigational Site | |
| Sendai, Miyagi, Japan | |
| Pfizer Investigational Site | |
| Beppu, Ohita, Japan | |
| Pfizer Investigational Site | |
| Kawaguchi, Saitama, Japan | |
| Pfizer Investigational Site | |
| Tokorozawa, Saitama, Japan | |
| Pfizer Investigational Site | |
| Arakawa-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Bunkyo-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Mitaka, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Nakano-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Shinagawa-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Shinjuku-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Fukuoka, Japan | |
| Pfizer Investigational Site | |
| Fukushima, Japan | |
| Pfizer Investigational Site | |
| Saitama, Japan | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00424372 History of Changes |
| Other Study ID Numbers: |
A0081121 |
| First Posted: | January 19, 2007 Key Record Dates |
| Results First Posted: | September 28, 2009 |
| Last Update Posted: | November 11, 2009 |
| Last Verified: | October 2009 |
Additional relevant MeSH terms:
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Neuralgia Neuralgia, Postherpetic Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Pregabalin Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |