Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

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NCT01049217

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Study Location
Southwest Center for HIV/AIDS
Phoenix, Arizona, 85006, United States
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Contact
1-800-718-1021
[email protected]
Related Links

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuropathy
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

- Men and women, ages of 18 or greater

- Documented evidence of HIV-1 infection

- Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain

- Pain starts in the feet

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


- Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or if
treated B12 deficiency -treatment is less than 6 months of B12 supplementation
(injection or intranasal B12) prior to screening


- Diabetes mellitus requiring regular medical treatment (other than diet and exercise)
or HbA1C >6.9


- Subjects with peripheral neuropathic pain that is not associated with HIV infection;
including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic
Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy,
radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related
to: metabolic abnormalities; nutritional factors; vascular insults; inflammation;
autoimmune disease; and malignancy

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NeuropathyPregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
NCT01049217
  1. Phoenix, Arizona
  2. Phoenix, Arizona
  3. Phoenix, Arizona
  4. Los Angeles, California
  5. Los Angeles, California
  6. Los Angeles, California
  7. North Hollywood, California
  8. Palm Springs, California
  9. San Diego, California
  10. Stanford, California
  11. Aventura, Florida
  12. Aventura, Florida
  13. Miami Beach, Florida
  14. Miami, Florida
  15. Tampa, Florida
  16. Atlanta, Georgia
  17. Atlanta, Georgia
  18. Decatur, Georgia
  19. Chicago, Illinois
  20. New York, New York
  21. Toledo, Ohio
  22. Toledo, Ohio
  23. Bellaire, Texas
  24. Dallas, Texas
  25. Houston, Texas
  26. Bogota, Cundinamarca
  27. Bogota, Cundinamarca
  28. Bogotá, Cundinamarca
  29. Bucaramanga, Santander
  30. Santo Domingo,
  31. Hyderabad, Andhra Pradesh
  32. Hyderabad, Andhra Pradesh
  33. Ahmedabad, Gujarat
  34. Mumbai, Maharashtra
  35. Pune, Maharashtra
  36. Chennai, Tamil Nadu
  37. Lima,
  38. Lima,
  39. Bydgoszcz,
  40. Chorzow,
  41. Ponce,
  42. Ponce,
  43. Rio Piedras,
  44. East London, Eastern Cape
  45. Port Elizabeth, Eastern Cape
  46. Benoni, Gauteng
  47. Johannesburg, Gauteng
  48. Johannesburg, Gauteng
  49. Johannesburg, Gauteng
  50. Pretoria West, Gauteng
  51. Pretoria, Gauteng
  52. Soweto, Gauteng
  53. Stanger, KwaZulu Natal
  54. Cape Town, Western Cape
  55. Durban,
  56. Gauteng,
  57. Middelburg,
  58. Paarl,
  59. Paarl,
  60. Pretoria,
  61. Tygerberg,
  62. Bangkok,
  63. Bangkok,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial Of Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081244)
Brief Summary The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
Detailed Description Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Neuropathy
Intervention  ICMJE
  • Drug: pregabalin
    Pregabalin 75 mg-300mg twice daily during the course of the study.
  • Drug: placebo
    Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.
Study Arms  ICMJE
  • Experimental: Active drug
    Intervention: Drug: pregabalin
  • Placebo Comparator: Control
    Intervention: Drug: placebo
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: May 6, 2013)		377
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2010)		422
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:

  • Men and women, ages of 18 or greater
  • Documented evidence of HIV-1 infection
  • Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain
  • Pain starts in the feet

Exclusion Criteria:

  • Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening
  • Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C >6.9
  • Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy
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,   Dominican Republic,   India,   Peru,   Poland,   Puerto Rico,   South Africa,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01049217
Other Study ID Numbers  ICMJE A0081244
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2013

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