Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00407511
First received: December 1, 2006
Last updated: October 8, 2009
Last verified: October 2009
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Purpose
Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Peripheral Neuropathic Pain (DPN) Postherpetic Neuralgia (PHN) HIV-related Neuropathic Pain (HIV) Chemotherapy Induced Neuropathic Pain |
Drug: Pregabalin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Open Label, Multi-Center, Study Of Pregabalin In The Treatment Of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, HIV-Related Peripheral Neuropathic Pain And Chemotherapy Induced Peripheral Neuropathic Pain |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) [ Time Frame: Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
- Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ] [ Designated as safety issue: No ]
- Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores [ Time Frame: Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF) ] [ Designated as safety issue: No ]
- Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ] [ Designated as safety issue: No ]
- Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ] [ Designated as safety issue: No ]
- Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF ] [ Designated as safety issue: No ]
- Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ] [ Designated as safety issue: No ]
- Change From Baseline in Mean Daily Sleep Interference Score (DSIS) [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF ] [ Designated as safety issue: No ]
- Patient Global Impression of Change (PGIC) [ Time Frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) ] [ Designated as safety issue: No ]
- Clinical Global Impression of Change (CGIC) [ Time Frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) ] [ Designated as safety issue: No ]
| Enrollment: | 121 |
| Study Start Date: | January 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pregabalin |
Drug: Pregabalin
Pregabalin will be administered orally, twice a day for 12 weeks, including 4-week dose adjustment phase followed by 8-week maintenance phase. The minimum allowable pregabalin dose during the trial will be 75 mg BID (150 mg/day) and the maximum allowable dose will be 300 mg BID (600 mg/day).
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who are diagnosed with neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.
Exclusion Criteria:
- Severe Pain associated with conditions other than Diabetic Peripheral Neuropathy, Post-Herpetic Neuralgia, Human Immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy that may confound assessment or self evaluation of the neuropathic pain.
- Skin Condition in the affected dermatome that (in the judgment of the investigator) could alter sensation.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407511
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407511
Locations
| Colombia | |
| Pfizer Investigational Site | |
| Bogota, Cundinamarca, Colombia | |
| Ecuador | |
| Pfizer Investigational Site | |
| Quito, Pichincha, Ecuador | |
| Mexico | |
| Pfizer Investigational Site | |
| Tijuana, B. C., Mexico, 22010 | |
| Pfizer Investigational Site | |
| Mexicali, B.c., Mexico, 21100 | |
| Pfizer Investigational Site | |
| Mexico, Distrito Federal, Mexico, 14080 | |
| Pfizer Investigational Site | |
| Acapulco, Guerrero, Mexico, 39670 | |
| Pfizer Investigational Site | |
| México, Monterrey, NL, Mexico, 64460 | |
| Pfizer Investigational Site | |
| Merida, Yucatan, Mexico, 97000 | |
| Peru | |
| Pfizer Investigational Site | |
| Lima, Peru, 27 | |
| Pfizer Investigational Site | |
| Lima, Peru, L13 | |
| Venezuela | |
| Pfizer Investigational Site | |
| Caracas, Distrito Capital, Venezuela, 1020 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer Inc. |
| ClinicalTrials.gov Identifier: | NCT00407511 History of Changes |
| Other Study ID Numbers: | A0081097 |
| Study First Received: | December 1, 2006 |
| Results First Received: | June 18, 2009 |
| Last Updated: | October 8, 2009 |
| Health Authority: | Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos |
Additional relevant MeSH terms:
|
Neuralgia Neuralgia, Postherpetic Diabetic Neuropathies Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Diabetes Complications Diabetes Mellitus Endocrine System Diseases 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 |
ClinicalTrials.gov processed this record on September 29, 2016