Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
NCT01455415
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- Type 1 or 2 diabetes with painful neuropathy
- Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
- Meet pre-defined level of pain severity at entrance
- History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
- Participated in a previous or ongoing pregabalin clinical trial
- Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment
of distal neuropathic pain
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Descriptive Information | ||||
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Brief Title ICMJE | Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain | |||
Official Title ICMJE | A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of Nsaid For Other Pain Conditions | |||
Brief Summary | This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Painful Diabetic Peripheral Neuropathy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Raskin P, Huffman C, Yurkewicz L, Pauer L, Scavone JM, Yang R, Parsons B. Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study. Clin J Pain. 2016 Mar;32(3):203-10. doi: 10.1097/AJP.0000000000000254. | |||
* 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 | Completed | |||
Actual Enrollment ICMJE | 306 | |||
Original Estimated Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | December 2013 | |||
Actual Primary Completion Date | November 2013 (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 | Czech Republic, Italy, Sweden, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01455415 | |||
Other Study ID Numbers ICMJE | A0081268 2011-002743-10 ( EudraCT Number ) | |||
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 |
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PRS Account | Pfizer | |||
Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |