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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 May 2013 |
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Main ID: |
NCT01455415 |
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Date of registration:
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17/10/2011 |
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Primary sponsor: |
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Public title:
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Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
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Scientific title:
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A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of NSAID For Other Pain Conditions |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01455415 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Czech Republic
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Italy
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Sweden
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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1-800-718-1021 |
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Email:
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Affiliation:
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Painful Diabetic Peripheral Neuropathy
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Intervention(s)
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Drug: placebo
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Drug: pregabalin
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Primary Outcome(s)
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Endpoint mean pain score, based on the mean of the last 7 daily pain numeric rating scale (NRS) scores from the daily pain diaries while receiving study medication in each treatment period
[Time Frame: 6 week]
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Secondary Outcome(s)
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Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
[Time Frame: 6 week]
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Daily Sleep Interference Rating Scale (Sleep Diary)
[Time Frame: 6 week]
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European Quality of Life in 5 Dimensions (EQ 5D)
[Time Frame: 6 week]
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Pain severity and impact using the Brief Pain Inventory - short form (BPI sf)
[Time Frame: 6 week]
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Patient Global Impression of Change assessed at the end of Period 1 (PGIC)
[Time Frame: 6 week]
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Proportions of 30% and 50% pain responders using NRS scores from the daily pain diary (Pain Diary)
[Time Frame: 6 week]
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Quality of life using Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QoL DN)
[Time Frame: 6 week]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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