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

• ClinicalTrials.gov Identifier: NCT00407511
• Recruitment Status: Completed
• First Posted: December 5, 2006
• Results First Posted: August 19, 2009
• Last Update Posted: October 15, 2009
• Sponsor: Pfizer
• Information provided by: Pfizer

Study Description

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

• 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

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

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 ]
   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.

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 ]
   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). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.
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 ]
   Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.
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) ]
   Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.
4. Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ]
   Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.
5. Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ]
   Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.
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 ]
   100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.
7. Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ]
   100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.
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 ]
   Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.
9. Patient Global Impression of Change (PGIC) [ Time Frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) ]
   7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)
10. Clinical Global Impression of Change (CGIC) [ Time Frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) ]
    7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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

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
• 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; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; 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; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs