Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
NCT01049217
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- 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
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 377 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
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 |