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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00407511
First received: December 1, 2006
Last updated: October 8, 2009
Last verified: October 2009
  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:
Neurologic Manifestations
Diabetes Complications
Neuralgia
Peripheral Nervous System Diseases
Neuralgia, Postherpetic
Diabetic Neuropathies
Pain
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
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 April 17, 2014