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

NCT00407511 | Completed Phase 4 Results

• 1 other identifier: A0081097
• Study Type: interventional
• Target: 121
• Locations: 5 countries
• Sites: 11

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.

Conditions

Diabetic Peripheral Neuropathic Pain (DPN); Postherpetic Neuralgia (PHN); HIV-related Neuropathic Pain (HIV); Chemotherapy Induced Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)

  11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.

  Baseline, End of Treatment

Secondary Outcomes (10)

• Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)

  Week 4, Week 8, Week 12

• Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores

  Baseline, Week 8, Week 12, EOT/LOCF

• Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores

  Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)

• Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication

  Baseline, Week 8, Week 12, EOT/LOCF

• Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication

  Baseline, Week 8, Week 12, EOT/LOCF

Study Arms (1)

Pregabalin

EXPERIMENTAL

Drug: Pregabalin

Interventions

Pregabalin DRUG

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).

Pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (11)

Pfizer Investigational Site

Bogota, Cundinamarca, Colombia

Location

Pfizer Investigational Site

Quito, Pichincha, Ecuador

Location

Pfizer Investigational Site

Tijuana, B. C., 22010, Mexico

Location

Pfizer Investigational Site

Mexicali, B.C., 21100, Mexico

Location

Pfizer Investigational Site

Acapulco de Juárez, Guerrero, 39670, Mexico

Location

Pfizer Investigational Site

Mexico City, Mexico City, 14080, Mexico

Location

Pfizer Investigational Site

México, Monterrey, NL, 64460, Mexico

Location

Pfizer Investigational Site

Mérida, Yucatán, 97000, Mexico

Location

Pfizer Investigational Site

Lima, 27, Peru

Location

Pfizer Investigational Site

Lima, L13, Peru

Location

Pfizer Investigational Site

Caracas, Distrito Federal, 1020, Venezuela

Location

Related Publications (1)

• 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.

  PMID: 20487048 DERIVED

Related Links

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

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 5, 2006
• Study Start: January 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 9, 2021
• Results First Posted: August 19, 2009

Record last verified: 2009-10

Locations

ME (6); CO (1); VE (1); EC (1); PE (2)