Diabetic Peripheral NeuropathyPhase 2NCT00641953
IMX-150 Cream for Diabetic Neuropathy
A Phase 2 study testing IMX-150 in people with Diabetic Peripheral Neuropathy, run by Procris Pharmaceuticals at 7 sites in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two different dose of IMX-150 to that of placebo (non-active) in the treatment of diabetic peripheral neuropathy pain of the feet. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- IMX-150
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2007to Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have sufficient command and understanding of the English language to complete diaries and questionnaires
- If female, may not be pregnant or lactating
- Can be treated on an outpatient basis
- Has a clinical diagnosis of Type-1 or Type II diabetes with: confirmed diagnosis of diabetic distal symmetrical sensorimotor polyneuropathy and bilateral pain in the feet for at least 3 months.
- Must have a hemoglobin A1C value of 11% or less that is stable under treatment
- Agrees to use the test creams as specified for the 4 week period
- Willing to not use any other medications, including investigational medications, to treat pain symptoms of Diabetic Neuropathy while in study.
Who cannot join
- Currently using any nitrate medications
- Currently using Viagra®, Levitra®, Cialis® or other phosphodiesterase 5 inhibitors medications for erectile dysfunction
- Currently treated for symptoms of diabetic neuropathy, including but not limited to Lyrica®, Cymbalta® and transcutaneous stimulation
- Not on a stable dose for at least 4 weeks prior to study screening of other vasodilators required for underlying conditions
- Know allergy to Nitroglycerin, propylene glycol or common moisturizing creams
- History of migraine, cluster or vascular headaches, chronic pain with greater pain intensity than the pain of diabetic neuropathy or other chronic pain condition within the region of the diabetic peripheral neuropathy
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- Amputation of more than one toe per foot
- Neurological disorder or skin condition that may alter local sensation in the feet
- History of unstable medical problem, clinically significant screening laboratory test or any current medical condition that would contraindicate the administration of the study mediation, interfere with the study evaluations, or interfere with the patient's ability to comply with the study
- History of drug (including cannabinoid) or alcohol abuse within the past year
- Cognitive or language difficulties that would impair completion of the pain assessment tool
- Within the past 3 months, have had either a myocardial infarction, uncontrolled hypotension, or uncontrolled hypertension
- Participated in a study of any investigational drug within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to Screening
- Major abdominal, thoracic or vascular surgery within 6 months of the first dose of study medication
- Open lesions in the area where the cream is to be applied
- Fertile patients who are unable or unwilling to comply with the contraceptive requirements during the study period
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Meriden Research
Brooksville, Florida, 34613
Health Awareness
Jupiter, Florida, 33458
International Research Associates, LLC
Miami, Florida, 33156
Hampton Roads Center for Clinical Research
Norfolk, Virginia, 23502
Peninsula Research
Ormond Beach, Florida, 32174
Alpha Medical Research
Oviedo, Florida, 32765
Meridien Research
St. Petersburg, Florida, 33709
About this study
Official title: A Randomized, Phase II, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Response Study of an Aqueous Topical Formulation of Nitroglycerin, IMX-150, in the Treatment of Pain in Diabetic Peripheral Neuropathy of the Feet
The purpose of this study is to compare the effectiveness of two different dose of IMX-150 to that of placebo (non-active) in the treatment of diabetic peripheral neuropathy pain of the feet.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- IMX-150, Placebo
- Keywords
- Foot Pain, Diabetic Neuropathy Pain, Diabetic Peripheral Neuropathy foot pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMX-150Drug
(0.3%) 0.5g topically BID to each foot for 4 weeks
IMX-150Drug
(0.6%) 0.5g topically BID to each foot for 4 weeks
PlaceboDrug
0.5 g topically BID to each foot for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | IMX-150 (0.3%) 0.5 g topically BID each foot Receives: Drug: IMX-150 |
| B | Experimental | IMX-150(0.6%) 0.5 g topically BID to each foot Receives: Drug: IMX-150 |
| C | Placebo comparator | Placebo 0.5 g topically BID to each foot for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to endpoint (Day 29) in the average of neuropathic foot daily pain "24 - Hour Average Pain" scores
Measured: Weekly average of "24-hour Average Pain"
Secondary outcomes (1)
Change in weekly average sleep disturbance
Measured: daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startAug 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procris Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patrick Yeramian, MD, Study director, VP Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641953
- Sponsor's protocol ID
- 01-004A
- Status last verified
- Jun 2008
- First submitted
- 17 Mar 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Response Study of an Aqueous Topical Formulation of Nitroglycerin, IMX-150, in the Treatment of Pain in Diabetic Peripheral Neuropathy of the Feet
- ClinicalTrials.gov ID
- NCT00641953
- Acronym / sponsor ID
- 01-004A
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Foot Pain, Diabetic Neuropathy Pain, Diabetic Peripheral Neuropathy foot pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Procris PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 24 Mar 2008 (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 compare the effectiveness of two different dose of IMX-150 to that of placebo (non-active) in the treatment of diabetic peripheral neuropathy pain of the feet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: IMX-150IMX-150 (0.3%) 0.5 g topically BID each foot |
| B | Experimental | Drug: IMX-150IMX-150(0.6%) 0.5 g topically BID to each foot |
| C | Placebo comparator | Drug: PlaceboPlacebo 0.5 g topically BID to each foot for 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have sufficient command and understanding of the English language to complete diaries and questionnaires
- If female, may not be pregnant or lactating
- Can be treated on an outpatient basis
- Has a clinical diagnosis of Type-1 or Type II diabetes with: confirmed diagnosis of diabetic distal symmetrical sensorimotor polyneuropathy and bilateral pain in the feet for at least 3 months.
- Must have a hemoglobin A1C value of 11% or less that is stable under treatment
Key exclusion criteria (16 listed)
- Currently using any nitrate medications
- Currently using Viagra®, Levitra®, Cialis® or other phosphodiesterase 5 inhibitors medications for erectile dysfunction
- Currently treated for symptoms of diabetic neuropathy, including but not limited to Lyrica®, Cymbalta® and transcutaneous stimulation
- Not on a stable dose for at least 4 weeks prior to study screening of other vasodilators required for underlying conditions
- Know allergy to Nitroglycerin, propylene glycol or common moisturizing creams
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 |
|---|---|---|
| IMX-150(0.3%) 0.5g topically BID to each foot for 4 weeks | Drug | A |
| IMX-150(0.6%) 0.5g topically BID to each foot for 4 weeks | Drug | B |
| Placebo0.5 g topically BID to each foot for 4 weeks | Drug | C |
Primary outcome
Change from Baseline to endpoint (Day 29) in the average of neuropathic foot daily pain "24 - Hour Average Pain" scores
Time frame: Weekly average of "24-hour Average Pain"
1 secondary outcome
Change in weekly average sleep disturbance
Time frame: daily
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 17 Jun 2008.
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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.
Patrick Yeramian, MD study director
VP Medical Affairs
7 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 IMX-150 in people with Diabetic Peripheral Neuropathy, run by Procris Pharmaceuticals at 7 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 7 inclusion and 16 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 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Change from Baseline to endpoint (Day 29) in the average of neuropathic foot daily pain "24 - Hour Average Pain" scores (time frame: Weekly average of "24-hour Average Pain"). 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 17 Jun 2008.