Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP

Study Description

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Brief Summary:

Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.

Condition or disease	Intervention/treatment	Phase
Diabetic Peripheral Neuropathic Pain (DPN); Postherpetic Neuralgia (PHN); HIV-related Neuropathic Pain (HIV); Chemotherapy Induced Neuropathic Pain	Drug: Pregabalin	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	121 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	January 2007
Actual Primary Completion Date :	July 2008
Actual Study Completion Date :	July 2008

Arms and Interventions

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Arm	Intervention/treatment
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).

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) [ Time Frame: Week 4, Week 8, Week 12 ]
2. 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 ]
3. 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) ]
4. Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ]
5. Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ]
6. 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 ]
7. Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ]
8. 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 ]
9. Patient Global Impression of Change (PGIC) [ Time Frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) ]
10. Clinical Global Impression of Change (CGIC) [ Time Frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Xochilcal-Morales M, Castro EM, Guajardo-Rosas J, Obregón TN, Acevedo JC, Chucan JM, Plancarte-Sanchez R, Davila G, Wajsbrot D, Guerrero M, Vinueza R. A prospective, open-label, multicentre study of pregabalin in the treatment of neuropathic pain in Latin America. Int J Clin Pract. 2010 Aug;64(9):1301-9. doi: 10.1111/j.1742-1241.2010.02389.x. Epub 2010 May 10.

Responsible Party:	Director, Clinical Trials Disclosure Group, Pfizer Inc.
ClinicalTrials.gov Identifier:	NCT00407511 History of Changes
Other Study ID Numbers:	A0081097
First Posted:	December 5, 2006
Results First Posted:	August 19, 2009
Last Update Posted:	October 15, 2009
Last Verified:	October 2009

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