PainPhase 3NCT00113620
Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy
A Phase 3 study testing Neurodex in people with Pain and Diabetic Neuropathy, run by Avanir Pharmaceuticals at 44 sites in United States.
Trial summary
The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Diabetic Neuropathy
- What is being tested?
- Neurodex
- How many people
- 450 participants
- Where
- 44 sitesUnited States
- Study dates
- Jul 2005to Feb 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus
- Established diabetic therapy for at least 3 months
- Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy
- Pain the previous three months
- Not pregnant
Who cannot join
- Patient failed adequate trial of 3 or more medications or has required narcotics for pain
- History of torsades de pointes
- Sensitivity to quinidine or opiate drugs (codeine, etc)
- Severe pain that could confound the assessment
- Patient has had any amputations
- Patient has participated in the past 30 days or is currently participating in another trial
- Patient has previously received treatment with dextromethorphan and quinidine
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Upstate Clinical Research, LLC
Albany, New York, 12205
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108
Knights Road Medical
Bensalem, Pennsylvania, 19020
Bay Area Foot Care
Castro Valley, California, 94546
Radiant Research
Cincinnati, Ohio, 45236
Tampa Bay Medical Research
Clearwater, Florida, 33761
Radiant Research
Dallas, Texas, 75231
University Clinical Research - DeLand
DeLand, Florida, 32720
Medisphere Medical Research Center, LLC
Evansville, Indiana, 47714
DiGiovanna Family Care Center
Great Neck, New York, 11021
Vital Research
Greensboro, North Carolina, 27408
Radiant Research - Greer
Greer, South Carolina, 29651
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Central Arkansas Research
Hot Springs, Arkansas, 71913
Nerve & Muscle Center of Texas
Houston, Texas, 77030
Investigative Clinical Reserach of Indiana, LLC
Indianapolis, Indiana, 46254
South Bay Clinical Research Inc.
Inglewood, California, 90301
Research Solutions
Jonesboro, Arkansas, 72401
FPA Clinical Research
Kissimmee, Florida, 34741
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, 90048
University of Wisconsin Medical School
Madison, Wisconsin, 53792
Pivotal Research Centers
Mesa, Arizona, 85210
Montana Neuroscience Institute
Missoula, Montana, 59802
Radiant Research - Akron
Mogadore, Ohio, 44260
Weill Medical College of Cornell University - Peripheral Neuropathy Center
New York, New York, 10022
Hampton Roads Center for Clinical Research
Norfolk, Virginia, 23502
Creighton Diabetes Center
Omaha, Nebraska, 68131
Crossroads Research, Inc.
Owings Mills, Maryland, 21117
Pacific Sleep Medicine Services, Inc.
Palm Springs, California, 92262
Northern California Research Group
Sacramento, California, 95831
Diabetes & Glandular Disease Research Assoc.
San Antonio, Texas, 78229
SAM Clinical Research
San Antonio, Texas, 78229
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117
Radiant Research - St. Louis
St Louis, Missouri, 63141
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701
Dedicate Clinical Research, Inc.
Sun City, Arizona, 85351
Neurology Clinical Research, Inc.
Sunrise, Florida, 33351
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23451
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Omega Medical Research
Warwick, Rhode Island, 02886
Laszlo J. Mate, MD
West Palm Beach, Florida, 33407
About this study
Official title: A Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dextromethorphan and Quinidine at Two Dose Levels in the Treatment of the Pain of Diabetic Neuropathy
The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.
- Conditions
- Pain, Diabetic Neuropathy
- Being tested
- Neurodex
- Keywords
- distal symmetrical, pain, lower extremities, dextromethorphan
- Medical subject headings
- Pain, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurodexDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain rating scale obtained from patient diaries
Secondary outcomes (1)
Additional diary rating scales and scores obtained from clinic visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2005 (estimated)
- Study startJul 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avanir Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113620
- Sponsor's protocol ID
- 04-AVR-109
- Status last verified
- Jul 2016
- First submitted
- 9 Jun 2005
- Last updated
- 14 Jul 2016
- Results posted
- No
Publications
Shaibani AI, Pope LE, Thisted R, Hepner A. Efficacy and safety of dextromethorphan/quinidine at two dosage levels for diabetic neuropathic pain: a double-blind, placebo-controlled, multicenter study. Pain Med. 2012 Feb;13(2):243-54. doi: 10.1111/j.1526-4637.2011.01316.x. Epub 2012 Feb 7.
PubMed 22314263
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dextromethorphan and Quinidine at Two Dose Levels in the Treatment of the Pain of Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00113620
- Acronym / sponsor ID
- 04-AVR-109
- Conditions
- Pain, Diabetic Neuropathy
- Keywords
- distal symmetrical, pain, lower extremities, dextromethorphan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Avanir PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 10 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of diabetes mellitus
- Established diabetic therapy for at least 3 months
- Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy
- Pain the previous three months
- Not pregnant
Key exclusion criteria (7 listed)
- Patient failed adequate trial of 3 or more medications or has required narcotics for pain
- History of torsades de pointes
- Sensitivity to quinidine or opiate drugs (codeine, etc)
- Severe pain that could confound the assessment
- Patient has had any amputations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodex | Drug | – |
Primary outcome
Pain rating scale obtained from patient diaries
1 secondary outcome
Additional diary rating scales and scores obtained from clinic visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Results publication: PubMed 22314263Shaibani AI, Pope LE, Thisted R, Hepner A. Efficacy and safety of dextromethorphan/quinidine at two dosage levels for diabetic neuropathic pain: a double-blind, placebo-controlled, multicenter study. Pain Med. 2012 Feb;13(2):243-54. doi: 10.1111/j.1526-4637.2011.01316.x. Epub 2012 Feb 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neurodex in people with Pain and Diabetic Neuropathy, run by Avanir Pharmaceuticals at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain rating scale obtained from patient diaries. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00113620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.