PainPhase 2NCT00375960
A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain
A Phase 2 study testing V3381 in people with Pain and Diabetic Neuropathies, run by Vernalis (R&D) Ltd at 6 sites in 2 countries.
Trial summary
The objective of this study is to investigate the safety and efficacy of an investigational drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's feet and legs, or even in one's hands and arms, sometimes experienced by people with diabetes). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Diabetic Neuropathies
- What is being tested?
- V3381
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jun 2006to Apr 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 18-75 years of age
- Diabetes mellitus (type I or type II)
- No change in medications for reducing blood sugar within 4 weeks before screening
- Experiencing daily pain due to diabetic neuropathy for at least 6 months but not more than 5 years
- Neuropathic pain must begin in the feet, with relatively symmetrical onset.
- Willing to perform self-monitoring of blood glucose
- Able to communicate intelligibly with the investigator and study coordinator
- Keeping all appointments for clinic visits, tests, and procedures
Who cannot join
- Any clinically significant neurologic disorders (with the exception of diabetic peripheral neuropathic pain)
- Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study
- Prior renal transplant or current renal dialysis
- Pernicious anemia
- Untreated hypothyroidism
- Amputations due to diabetes mellitus (with the exception of toes)
Show all 22Show fewer
- Any clinically significant abnormal electrocardiogram (ECG)
- Any history of cardiac arrhythmia
- History of myocardial infarction
- Active angina
- Uncontrolled hypertension (i.e., > 140/90 mm Hg)
- Known or at high risk of hepatitis B or C infection
- Known or at high risk of human immunodeficiency virus (HIV) infection
- Any anticipated need for surgery during the study
- Glycosylated hemoglobin (HbA1c) > 9%
- Known seizure disorder
- Any malignancy in the past 2 years (with the exception of basal cell carcinoma)
- Pain that cannot be clearly differentiated from, or conditions that interfere with the assessment of diabetic neuropathic pain.
- Use of anticonvulsants, antidepressants, or prescription membrane-stabilizing agents
- History of substance abuse or dependence within the past year, excluding nicotine and caffeine
- Frequent and/or severe allergic reactions with multiple medications
- Participation in any clinical trial within 30 days before screening
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Translational Pain Research Group, Brigham & Women's Hospital
Boston, Massachusetts, 02115
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Diabetes & Glandular Disease Research Associates Inc.
San Antonio, Texas, 78299-4801
American Center for Clinical Trials
Southfield, Michigan, 48034
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Crossover Study of the Safety, Efficacy and Pharmacokinetics of Two Escalating, Oral Doses of V3381 (200 mg BID and 400 mg BID) for 28 Days in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
The objective of this study is to investigate the safety and efficacy of an investigational drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's feet and legs, or even in one's hands and arms, sometimes experienced by people with diabetes). An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) and/or Health Canada.
Read the detailed description
Diabetic Peripheral Neuropathic Pain (DPNP) is pain in your feet and legs, or even in your hands and arms, sometimes experienced by people with diabetes. Neuropathic pain syndromes are much more common than is perhaps generally recognized. Approximately 1% of the population in western countries suffers from neuropathic pain. Some clinical conditions are associated with a relatively high incidence of neuropathic pain. Approximately 15% of patients with diabetic neuropathy have persistent neuropathic pain in the feet, legs and hands.
- Conditions
- Pain, Diabetic Neuropathies
- Being tested
- V3381, Placebo
- Keywords
- Pain associated with diabetes Type I or Type II, Neuropathic Pain due to diabetes, Diabetic peripheral neuropathic pain, Pain, Diabetes with burning sensation in the arms and/or legs, Diabetes with tingling sensation in the arms and/or legs, Neuropathic Pain Due to Diabetes Type I or Type II
- 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.
V3381Drug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
11 point numerical pain rating scale (NPRS) daily diary
Secondary outcomes (9)
Modified Brief Pain Inventory for DPN
McGill Pain Questionnaire - Short Form
Neuropathic Pain Symptom Inventory
Medical Outcomes Survey Short Form - 12, Version 2
Patient Global Impression of Change
Patient Preference Questionnaire (end of 2nd treatment period only)
Clinical Global Impression of Change
Additional secondary assessments will be included in the daily diary: consumption of rescue analgesics
daily sleep interference score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startJun 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Vernalis (R&D) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cita NeuroPharmaceuticals
- Investigators
- Christine Sang, M.D., MPH, Principal investigator, Brigham and Women's Hospital, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375960
- Sponsor's protocol ID
- V3381-2DPNP01
- Status last verified
- Mar 2007
- First submitted
- 11 Sep 2006
- Last updated
- 2 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Crossover Study of the Safety, Efficacy and Pharmacokinetics of Two Escalating, Oral Doses of V3381 (200 mg BID and 400 mg BID) for 28 Days in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
- ClinicalTrials.gov ID
- NCT00375960
- Acronym / sponsor ID
- V3381-2DPNP01
- Conditions
- Pain, Diabetic Neuropathies
- Keywords
- Pain associated with diabetes Type I or Type II, Neuropathic Pain due to diabetes, Diabetic peripheral neuropathic pain, Pain, Diabetes with burning sensation in the arms and/or legs, Diabetes with tingling sensation in the arms and/or legs, Neuropathic Pain Due to Diabetes Type I or Type II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Vernalis (R&D) LtdIndustry (pharma, biotech, devices)
- Collaborators
- Cita NeuroPharmaceuticals
- Study start
- Jun 2006
- Study completion
- Apr 2007
- First posted
- 13 Sep 2006 (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 objective of this study is to investigate the safety and efficacy of an investigational drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's feet and legs, or even in one's hands and arms, sometimes experienced by people with diabetes). An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) and/or Health Canada.
Detailed description
Diabetic Peripheral Neuropathic Pain (DPNP) is pain in your feet and legs, or even in your hands and arms, sometimes experienced by people with diabetes. Neuropathic pain syndromes are much more common than is perhaps generally recognized. Approximately 1% of the population in western countries suffers from neuropathic pain. Some clinical conditions are associated with a relatively high incidence of neuropathic pain. Approximately 15% of patients with diabetic neuropathy have persistent neuropathic pain in the feet, legs and hands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females 18-75 years of age
- Diabetes mellitus (type I or type II)
- No change in medications for reducing blood sugar within 4 weeks before screening
- Experiencing daily pain due to diabetic neuropathy for at least 6 months but not more than 5 years
- Neuropathic pain must begin in the feet, with relatively symmetrical onset.
Key exclusion criteria (22 listed)
- Any clinically significant neurologic disorders (with the exception of diabetic peripheral neuropathic pain)
- Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study
- Prior renal transplant or current renal dialysis
- Pernicious anemia
- Untreated hypothyroidism
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 |
|---|---|---|
| V3381 | Drug | – |
| Placebo | Drug | – |
Primary outcome
11 point numerical pain rating scale (NPRS) daily diary
9 secondary outcomes
Modified Brief Pain Inventory for DPN
McGill Pain Questionnaire - Short Form
Neuropathic Pain Symptom Inventory
Medical Outcomes Survey Short Form - 12, Version 2
Patient Global Impression of Change
Patient Preference Questionnaire (end of 2nd treatment period only)
Clinical Global Impression of Change
Additional secondary assessments will be included in the daily diary: consumption of rescue analgesics
daily sleep interference score
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 2 Apr 2007.
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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.
Christine Sang, M.D., MPH principal investigator
Brigham and Women's Hospital, Harvard Medical School
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V3381 in people with Pain and Diabetic Neuropathies, run by Vernalis (R&D) Ltd at 6 sites in 2 countries.
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 8 inclusion and 22 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 2 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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 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?
11 point numerical pain rating scale (NPRS) daily diary. 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 2 Apr 2007.