Diabetic NeuropathyPhase 2NCT00568035
Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy
A Phase 2 study testing QR-333 in people with Diabetic Neuropathy, run by Quigley Pharma, Inc. at 19 sites in United States.
Trial summary
The purpose of this study is to determine whether QR-333 is safe and effective in the treatment of diabetic neuropathy as compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- QR-333
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 19 sitesUnited States
- Study dates
- Dec 2006to Nov 2008
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of diabetic neuropathy
- must have some pain daily in the lower limbs due to diabetic polyneuropathy for at least 3 months prior to enrollment
- must be willing to comply with study directions, write information in a diary (such as pain medications taken), read and comprehend written instructions, complete questionnaires, and have the ability to apply the cream as directed
Who cannot join
- uncontrolled pain that has persisted for > 12 months.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Hartwell Research Group / Anderson Family Care
Anderson, South Carolina, 29621
Parkway Medical Center
Birmingham, Alabama, 35215
Seale Harris Clinic / Alliance Clinical Research
Birmingham, Alabama, 35216
Kaleida Health, Diabetes Center of WNY
Buffalo, New York, 14209
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Pacific Sleep Medicine Services, Inc
Fountain Valley, California, 92708
ECU Diabetes Research Center, Brody School of Medicine
Greenville, North Carolina, 27834
Advanced Medical Research, LLC
Lakewood, California, 90712
Rwjms/Umdnj
New Brunswick, New Jersey, 08903
Renstar Medical Research
Ocala, Florida, 34471
Baptist Clinical Research
Pensacola, Florida, 35201
Rainier Clinical Research Center, Inc
Renton, Washington, 98057
dgd Research
San Antonio, Texas, 78229
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229
A&A Pain Institute
St Louis, Missouri, 63141
Stedman Clinical Trails
Tampa, Florida, 33613
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Land Clinical Studies
West Caldwell, New Jersey, 07006
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
About this study
Official title: Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy
The purpose of this study is to determine whether QR-333 is safe and effective in the treatment of diabetic neuropathy as compared to placebo.
Read the detailed description
Diabetic neuropathy is among the most common complication of diabetes, resulting in pain and numbness, which affects the patients sleep, functioning and well-being. The pain is often accompanied by unpleasant sensations described as buzzing, cramp-like, burning, or jolting. The pain is usually symmetrical and occurs in the upper and lower extremities following a "glove and stocking" distribution.
To date there is no fully effective treatment for diabetic neuropathy. Therapy is tailored individually according to subject complaints and may be selected from categories including Non-steroidal anti-inflammatory drugs (NSAIDs) and adjuvant analgesics (including tricyclic antidepressants and anticonvulsants).
The clinical trial is being conducted to determine the safety and efficacy of QR-333 in the treatment of diabetic neuropathy as compared to placebo.
- Conditions
- Diabetic Neuropathy
- Being tested
- QR-333
- Keywords
- diabetic, peripheral, neuropathy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QR-333Drug
QR-333 or placebo will be applied three times a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| QR-333 | Active comparator | Not described Receives: Drug: QR-333 |
| Placebo | Placebo comparator | Not described Receives: Drug: QR-333 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety of a three times daily application of QR-333 as compared to placebo.
Measured: 12 Weeks
Secondary outcomes (1)
Determine the efficacy of QR-333 on symptoms of diabetic neuropathy and the impact of QR-333 on the daily activities (including pain and sleep disturbance) of subjects with symptomatic diabetic neuropathy as compared to placebo.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startDec 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quigley Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip Raskin, MD, Study chair, University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568035
- Sponsor's protocol ID
- QR-333-002
- Status last verified
- Jan 2009
- First submitted
- 3 Dec 2007
- Last updated
- 8 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00568035
- Acronym / sponsor ID
- QR-333-002
- Conditions
- Diabetic Neuropathy
- Keywords
- diabetic, peripheral, neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Quigley Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 5 Dec 2007 (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 QR-333 is safe and effective in the treatment of diabetic neuropathy as compared to placebo.
Detailed description
Diabetic neuropathy is among the most common complication of diabetes, resulting in pain and numbness, which affects the patients sleep, functioning and well-being. The pain is often accompanied by unpleasant sensations described as buzzing, cramp-like, burning, or jolting. The pain is usually symmetrical and occurs in the upper and lower extremities following a "glove and stocking" distribution.
To date there is no fully effective treatment for diabetic neuropathy. Therapy is tailored individually according to subject complaints and may be selected from categories including Non-steroidal anti-inflammatory drugs (NSAIDs) and adjuvant analgesics (including tricyclic antidepressants and anticonvulsants).
The clinical trial is being conducted to determine the safety and efficacy of QR-333 in the treatment of diabetic neuropathy as compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QR-333 | Active comparator | Drug: QR-333 |
| Placebo | Placebo comparator | Drug: QR-333 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of diabetic neuropathy
- must have some pain daily in the lower limbs due to diabetic polyneuropathy for at least 3 months prior to enrollment
- must be willing to comply with study directions, write information in a diary (such as pain medications taken), read and comprehend written instructions, complete questionnaires, and have the ability to apply the cream as directed
Key exclusion criteria (1 listed)
- uncontrolled pain that has persisted for > 12 months.
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 |
|---|---|---|
| QR-333QR-333 or placebo will be applied three times a day for 12 weeks | Drug | Placebo, QR-333 |
Primary outcome
Determine the safety of a three times daily application of QR-333 as compared to placebo.
Time frame: 12 Weeks
1 secondary outcome
Determine the efficacy of QR-333 on symptoms of diabetic neuropathy and the impact of QR-333 on the daily activities (including pain and sleep disturbance) of subjects with symptomatic diabetic neuropathy as compared to placebo.
Time frame: 12 weeks
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 8 Jan 2009.
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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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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.
Philip Raskin, MD study chair
University of Texas, Southwestern Medical Center at Dallas
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QR-333 in people with Diabetic Neuropathy, run by Quigley Pharma, Inc. at 19 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 3 inclusion and 1 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 8 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Determine the safety of a three times daily application of QR-333 as compared to placebo. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2009.