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

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NCT01049217

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Southwest Center for HIV/AIDS
Phoenix, Arizona, 85006 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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 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

NCT01049217
Pfizer
Terminated
Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

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Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
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)
The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Neuropathy
  • 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.
  • Experimental: Active drug
    Intervention: Drug: pregabalin
  • Placebo Comparator: Control
    Intervention: Drug: placebo
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.
 
Terminated
377
May 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Colombia,   Dominican Republic,   India,   Peru,   Poland,   Puerto Rico,   South Africa,   Thailand,   United States
 
 
NCT01049217
A0081244
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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