Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
This study is currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01455415
First received: October 17, 2011
Last updated: May 16, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Painful Diabetic Peripheral Neuropathy |
Drug: pregabalin Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of NSAID For Other Pain Conditions |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportions of 30% and 50% pain responders using NRS scores from the daily pain diary (Pain Diary) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
- Patient Global Impression of Change assessed at the end of Period 1 (PGIC) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
- Daily Sleep Interference Rating Scale (Sleep Diary) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
- Quality of life using Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QoL DN) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
- European Quality of Life in 5 Dimensions (EQ 5D) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
- Pain severity and impact using the Brief Pain Inventory - short form (BPI sf) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
- Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1: Pregabalin |
Drug: pregabalin
150 - 300 mg/day in divided dose (3 time a day) for 6 weeks
|
| Placebo Comparator: 2: Placebo |
Drug: placebo
matching placebo 3 time a day
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455415
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Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Hide Study LocationsLocations
| United States, Arizona | |
| Dedicated Clinical Research | Recruiting |
| Goodyear, Arizona, United States, 85395 | |
| Clinical Research Consortium | Recruiting |
| Phoenix, Arizona, United States, 85004 | |
| Precision Trials | Recruiting |
| Phoenix, Arizona, United States, 85032 | |
| The Office of Joshua D. Holland, M.D. | Recruiting |
| Phoenix, Arizona, United States, 85053 | |
| Advanced Podiatry | Recruiting |
| Phoenix, Arizona, United States, 85032 | |
| Clinical Research Consortium Arizona | Recruiting |
| Phoenix, Arizona, United States, 85003 | |
| Genova Clinical Research | Recruiting |
| Tucson, Arizona, United States, 85704 | |
| United States, California | |
| Neuro-Pain Medical Center | Recruiting |
| Fresno, California, United States, 93710 | |
| Center for United Research, Inc. | Recruiting |
| Lakewood, California, United States, 90712 | |
| IDS Pharmacy | Recruiting |
| Los Angeles, California, United States, 90033 | |
| HealthCare Partners Medical Group | Recruiting |
| Los Angeles, California, United States, 90015 | |
| University of Southern California | Recruiting |
| Los Angeles, California, United States, 90033 | |
| United States, Connecticut | |
| Neurological Group, PC | Recruiting |
| New London, Connecticut, United States, 06320 | |
| Coastal Connecticut Research, LLC | Recruiting |
| New London, Connecticut, United States, 06320 | |
| Chase Medical Research, LLC | Active, not recruiting |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| Meridien Research | Recruiting |
| Bradenton, Florida, United States, 34208 | |
| Meridien Research | Recruiting |
| Brooksville, Florida, United States, 34601 | |
| Gulfcoast Clinical Research Center | Recruiting |
| Fort Myers, Florida, United States, 33912 | |
| MD Clinical | Recruiting |
| Hallandale Beach, Florida, United States, 33009 | |
| Palm Beach Neurological Center, | Terminated |
| Palm Beach Gardens, Florida, United States, 33418 | |
| Meridien Research | Recruiting |
| St. Petersburg, Florida, United States, 33709 | |
| Meridien Research | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Clinical Research of Central Florida | Recruiting |
| Winter Haven, Florida, United States, 33880 | |
| United States, Georgia | |
| Columbus Research Foundation | Recruiting |
| Columbus, Georgia, United States, 31904 | |
| United States, Illinois | |
| Suburban Clinical Research | Active, not recruiting |
| Chicago, Illinois, United States, 60624 | |
| Suburban Clinical Research | Recruiting |
| Naperville, Illinois, United States, 60564 | |
| United States, Kentucky | |
| Central Kentucky Research Associates, Inc. | Recruiting |
| Lexington, Kentucky, United States, 40509 | |
| United States, Louisiana | |
| Arthritis and Diabetes Clinic, Inc. | Recruiting |
| Monroe, Louisiana, United States, 71203 | |
| United States, Massachusetts | |
| Miray Medical Center | Recruiting |
| Brockton, Massachusetts, United States, 02301 | |
| Beacon Clinical Research, LLC | Recruiting |
| Brockton, Massachusetts, United States, 02301 | |
| Genesis Clinical Research, LLC | Recruiting |
| Fall River, Massachusetts, United States, 02720 | |
| United States, Michigan | |
| Borgess Research Institute | Terminated |
| Kalamazoo, Michigan, United States, 49048 | |
| Borgess Diabetes Center | Terminated |
| Kalamazoo, Michigan, United States, 49048 | |
| United States, Missouri | |
| Mercy Health Research | Terminated |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Quality Clinical Research, Inc. | Recruiting |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| Mirkil Medical Group | Recruiting |
| Las Vegas, Nevada, United States, 89119 | |
| Clinical Research Consortium | Recruiting |
| Las Vegas, Nevada, United States, 89119 | |
| United States, New York | |
| The Medical Research Network, LLC | Recruiting |
| New York, New York, United States, 10128 | |
| United States, Ohio | |
| Radiant Research | Recruiting |
| Columbus, Ohio, United States, 43212 | |
| United States, Oklahoma | |
| Sooner Clinical Research | Recruiting |
| Oklahoma City, Oklahoma, United States, 73112 | |
| The Office of Veronique Sebastian, MD | Recruiting |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Oregon | |
| Sunstone Medical Research, LLC | Recruiting |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| Blair Orthopedic Associates, Inc. | Recruiting |
| Altoona, Pennsylvania, United States, 16602 | |
| Altoona Center for Clinical Research | Recruiting |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, South Carolina | |
| Neurology and Pain Clinic, LLC | Terminated |
| Orangeburg, South Carolina, United States, 29118 | |
| United States, Tennessee | |
| New Phase Research and Development | Recruiting |
| Knoxville, Tennessee, United States, 37919 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Houston Neurocare | Recruiting |
| Houston, Texas, United States, 77030 | |
| Centex Research, Inc. | Recruiting |
| Houston, Texas, United States, 77062 | |
| Czech Republic | |
| UNARS, s.r.o. | Recruiting |
| Pelhrimov, Czech Republic, 39301 | |
| Clintrial, s.r.o. | Recruiting |
| Praha 10, Czech Republic, 100 00 | |
| Fakultni nemocnice v Motole | Recruiting |
| Praha 5, Czech Republic, 150 06 | |
| Italy | |
| A.O.U. San Martino, DIMI, Dipartimento Medicina Interna e Specialita Mediche, Clinica Gerontologica | Not yet recruiting |
| Genova, Italy, 16132 | |
| Dipartimento di Medicina Interna e Specialit�ediche � DI.M.I. | Not yet recruiting |
| Genova, Italy, 16132 | |
| IRCCS A.O.U. San Martino � IST | Not yet recruiting |
| Genova, Italy, 16132 | |
| U.O. Complessa di Diabetologia e Dietetica � ULSS 16 | Not yet recruiting |
| Padova, Italy, 35143 | |
| Universit�egli Studi di Roma La Sapienza | Recruiting |
| Roma, Italy, 00185 | |
| Fondazione PTV Policlinico Tor Vergata di Roma | Recruiting |
| Roma, Italy, 00133 | |
| Sweden | |
| Forskningsmottagningen Gamla Sjukhuset i Falkoping | Recruiting |
| Falkoping, Sweden, 521 43 | |
| Center for Lakemedelsstudier | Recruiting |
| Malmo, Sweden, 211 52 | |
| Citydiabetes | Recruiting |
| Stockholm, Sweden, 111 57 | |
| Bragee Medect AB | Recruiting |
| Stockholm, Sweden, 115 22 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01455415 History of Changes |
| Other Study ID Numbers: | A0081268 |
| Study First Received: | October 17, 2011 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pain Peripheral Nervous System Diseases Diabetic Neuropathies Neurologic Manifestations Nervous System Diseases Signs and Symptoms Neuromuscular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal |
Pregabalin Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Central Nervous System Agents Anticonvulsants |
ClinicalTrials.gov processed this record on May 16, 2013