Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

NCT01057693

Last updated date
Study Location
Greystone Medical Research, LLC
Birmingham, Alabama, 35242, United States
Contact
1-800-718-1021

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

- Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.

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


- Patients with other pain conditions cannot participate.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
Official Title  ICMJE A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY
Brief Summary Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy, Painful
Intervention  ICMJE
  • Drug: pregabalin (Lyrica)
    Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
  • Drug: Placebo
    Placebo is supplied as capsules and given 3 times daily.
Study Arms  ICMJE
  • Experimental: pregabalin (Lyrica)
    Intervention: Drug: pregabalin (Lyrica)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Raskin P, Huffman C, Toth C, Asmus MJ, Messig M, Sanchez RJ, Pauer L. Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. Clin J Pain. 2014 May;30(5):379-90. doi: 10.1097/AJP.0b013e31829ea1a1.

*   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
 (submitted: February 1, 2019)
633
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2010)
564
Actual Study Completion Date  ICMJE January 30, 2012
Actual Primary Completion Date January 30, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.

Exclusion Criteria:

  • Patients with other pain conditions cannot participate.
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 Canada,   Puerto Rico,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01057693
Other Study ID Numbers  ICMJE A0081242
2009-017389-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2019

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