Pregabalin Trial In HIV Neuropathic Pain

NCT01145417

Last updated date
Study Location
Southwest Center for HIV/AIDS
Phoenix, Arizona, 85006, United States
Contact
1-800-718-1021

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By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1 Infection, Neuropathic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who participated in the preceding A0081244 double-blind trial and completed at least through Visit 9 of that trial.

Subjects with painful distal sensory polyneuropathy (DSP) interested in treatment based on investigator's clinical judgment.

Subjects who had acceptable tolerability of study drug in A0081244.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Clinically significant or unstable conditions that, in the opinion of the
investigator, would compromise participation in the study. This includes, for example,
medical conditions such as, but not limited to: hepatic, renal, respiratory,
hematological, immunological, cardiovascular diseases, arrhythmia, inflammatory or
rheumatologic disease, active infections, symptomatic peripheral vascular disease,
psychiatric illness, and untreated endocrine disorders.


- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.


- Active Acquired Immune Deficiency Syndrome (AIDS)- defining Opportunistic Infection
(OI) that requires hospitalization.

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Pfizer Clinical Trials Contact Center

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[email protected]

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HIV-1 Infection, Neuropathic PainPregabalin Trial In HIV Neuropathic Pain
NCT01145417
  1. Phoenix, Arizona
  2. Phoenix, Arizona
  3. Burbank, California
  4. Palm Springs, California
  5. Palm Springs, California
  6. San Diego, California
  7. Stanford, California
  8. Aventura, Florida
  9. Aventura, Florida
  10. New York, New York
  11. Bogota D.C., Cundinamarca
  12. Bogota, Cundinamarca
  13. Hyderabad, Andhra Pradesh
  14. Ahemdabad, Gujarat
  15. Pune, Maharashtra
  16. Lima,
  17. Rio Piedras,
  18. Port Elizabeth, Eastern Cape
  19. Benoni, Gauteng
  20. Johannesburg, Gauteng
  21. Johannesburg, Gauteng
  22. Pretoria West, Gauteng
  23. Stanger, KwaZulu Natal
  24. Cape Town, Western Cape
  25. Durban,
  26. Paarl,
  27. Paarl,
  28. Bangkok,
  29. Bangkok,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pregabalin Trial In HIV Neuropathic Pain
Official Title  ICMJE An Open-Label, Extension Safety Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081251)
Brief Summary This study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with HIV infection as an extension of another trial that tests the efficacy of pregabalin.
Detailed Description The parent double blind study was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated simultaneously on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV-1 Infection
  • Neuropathic Pain
Intervention  ICMJE Drug: pregabalin (Lyrica)
150 mg-600 mg/day (twice daily)
Study Arms  ICMJE Experimental: Pregabalin (Lyrica)
Intervention: Drug: pregabalin (Lyrica)
Publications * Simpson DM, Rice AS, Emir B, Landen J, Semel D, Chew ML, Sporn J. A randomized, double-blind, placebo-controlled trial and open-label extension study to evaluate the efficacy and safety of pregabalin in the treatment of neuropathic pain associated with human immunodeficiency virus neuropathy. Pain. 2014 Oct;155(10):1943-54. doi: 10.1016/j.pain.2014.05.027. Epub 2014 Jun 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 18, 2013)
217
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2010)
400
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who participated in the preceding A0081244 double-blind trial and completed at least through Visit 9 of that trial.

Subjects with painful distal sensory polyneuropathy (DSP) interested in treatment based on investigator's clinical judgment.

Subjects who had acceptable tolerability of study drug in A0081244.

Exclusion Criteria:

  • Clinically significant or unstable conditions that, in the opinion of the investigator, would compromise participation in the study. This includes, for example, medical conditions such as, but not limited to: hepatic, renal, respiratory, hematological, immunological, cardiovascular diseases, arrhythmia, inflammatory or rheumatologic disease, active infections, symptomatic peripheral vascular disease, psychiatric illness, and untreated endocrine disorders.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Active Acquired Immune Deficiency Syndrome (AIDS)- defining Opportunistic Infection (OI) that requires hospitalization.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia,   India,   Peru,   Puerto Rico,   South Africa,   Thailand,   United States
Removed Location Countries Dominican Republic,   Poland
 
Administrative Information
NCT Number  ICMJE NCT01145417
Other Study ID Numbers  ICMJE A0081251
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP