Clinical trial NCT00407511: Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Peripheral Neuropathic Pain (DPN)
Postherpetic Neuralgia (PHN)
HIV-related Neuropathic Pain (HIV)
Chemotherapy Induced Neuropathic Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-05
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
timeFrame: Baseline, End of Treatment
Secondary outcomes:
measure: Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
timeFrame: Week 4, Week 8, Week 12
measure: Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
timeFrame: Baseline, Week 8, Week 12, EOT/LOCF
measure: Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores
timeFrame: Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)
measure: Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
timeFrame: Baseline, Week 8, Week 12, EOT/LOCF
measure: Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
timeFrame: Baseline, Week 8, Week 12, EOT/LOCF
measure: Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF
measure: Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)
timeFrame: Baseline, Week 8, Week 12, EOT/LOCF
measure: Change From Baseline in Mean Daily Sleep Interference Score (DSIS)
timeFrame: 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
measure: Patient Global Impression of Change (PGIC)
timeFrame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)
measure: Clinical Global Impression of Change (CGIC)
timeFrame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Quito
country: Ecuador
facility: Pfizer Investigational Site
state: Pichincha
city: Tijuana
country: Mexico
facility: Pfizer Investigational Site
state: B. C.
city: Mexicali
country: Mexico
facility: Pfizer Investigational Site
state: B.c.
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: Distrito Federal
city: Acapulco
country: Mexico
facility: Pfizer Investigational Site
state: Guerrero
city: México
country: Mexico
facility: Pfizer Investigational Site
state: Monterrey, NL
city: Merida
country: Mexico
facility: Pfizer Investigational Site
state: Yucatan
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Distrito Capital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Xochilcal-Morales M, Castro EM, Guajardo-Rosas J, Obregon 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.