ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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.
- 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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| 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 |
| |||
| 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 | 217 | |||
| Original Estimated Enrollment ICMJE | 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 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:
| |||
| Sex/Gender ICMJE |
| |||
| 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 ( 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 |
| |||
| 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 | ||||