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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
| 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
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, L13 | |
| Pfizer Investigational Site | |
| Lima, Peru, 27 | |
| 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:
No publications provided by Pfizer
Additional 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 Peripheral Nervous System Diseases Neuralgia, Postherpetic Diabetic Neuropathies Pain Neurologic Manifestations 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 Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 23, 2013