Diabetic NeuropathyPhase 3NCT00661063
Diabetic Neuropathy Topical Treatment
A Phase 3 study testing ketamine, ketamine + clonidine and clonidine gel 1% in people with Diabetic Neuropathy and Pain, run by Irmandade da Santa Casa de Misericordia de Sao Paulo at 1 site in Brazil.
Trial summary
Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Pain
- What is being tested?
- ketamine, ketamine + clonidine and clonidine gel 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2008to Jun 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes Mellitus type I or II
- Mono or polyneuropathy
- Treatment with Tricyclic Antidepressant, Carbamazepine during 3 weeks at least
- Preserved cognition
Who cannot join
- Ulcerative or infection or vesicle lesion in pain site
- Pregnancy
- Breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetic Neuropathic Pain Topical Treatment- Comparative Study
Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain
- Conditions
- Diabetic Neuropathy, Pain
- Being tested
- ketamine, vehicle gel, ketamine + clonidine, clonidine gel 1%
- Keywords
- neuropathic pain, ketamine, clonidine, association
- Medical subject headings
- Diabetic Neuropathies, Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
ketamine 150 mcg/g bid
vehicle gelDrug
bid - 12 weeks
ketamine + clonidineDrug
ketamine 150mcg/g + clonidine 1% gel bid 12 weeks
clonidine gel 1%Drug
bid 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| K | Experimental | drug - ketamine 1% gel Receives: Drug: ketamine |
| P | Placebo comparator | vehicle gel Receives: Drug: vehicle gel |
| M | Experimental | association of ketamine and clonidine gel Receives: Drug: ketamine + clonidine |
| C | Experimental | clonidine gel Receives: Drug: clonidine gel 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain evaluation by visual analogue scale
Measured: 12 weeks
Secondary outcomes (1)
pain evaluation by amount of rescue medication required
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 posted18 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009 (estimated)
- Study completionJun 2009 (estimated)
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Judymara L Gozzani, Investigator, Principal investigator, Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661063
- Sponsor's protocol ID
- 042/2007
- Status last verified
- Apr 2008
- First submitted
- 15 Apr 2008
- Last updated
- 18 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Serednicki WT, Wrzosek A, Woron J, Garlicki J, Dobrogowski J, Jakowicka-Wordliczek J, Wordliczek J, Zajaczkowska R. Topical clonidine for neuropathic pain in adults. Cochrane Database Syst Rev. 2022 May 19;5(5):CD010967. doi: 10.1002/14651858.CD010967.pub3.
PubMed 35587172
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Neuropathic Pain Topical Treatment- Comparative Study
- ClinicalTrials.gov ID
- NCT00661063
- Acronym / sponsor ID
- 042/2007
- Conditions
- Diabetic Neuropathy, Pain
- Keywords
- neuropathic pain, ketamine, clonidine, association
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de Sao PauloUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 18 Apr 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.
Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| K | Experimental | Drug: ketaminedrug - ketamine 1% gel |
| P | Placebo comparator | Drug: vehicle gelvehicle gel |
| M | Experimental | Drug: ketamine + clonidineassociation of ketamine and clonidine gel |
| C | Experimental | Drug: clonidine gel 1%clonidine gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes Mellitus type I or II
- Mono or polyneuropathy
- Treatment with Tricyclic Antidepressant, Carbamazepine during 3 weeks at least
- Preserved cognition
Key exclusion criteria (3 listed)
- Ulcerative or infection or vesicle lesion in pain site
- Pregnancy
- Breast feeding
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 |
|---|---|---|
| ketamineketamine 150 mcg/g bid | Drug | K |
| vehicle gelbid - 12 weeks | Drug | P |
| ketamine + clonidineketamine 150mcg/g + clonidine 1% gel bid 12 weeks | Drug | M |
| clonidine gel 1%bid 12 weeks | Drug | C |
Primary outcome
pain evaluation by visual analogue scale
Time frame: 12 weeks
1 secondary outcome
pain evaluation by amount of rescue medication required
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2008.
- Derived from this study: PubMed 35587172Serednicki WT, Wrzosek A, Woron J, Garlicki J, Dobrogowski J, Jakowicka-Wordliczek J, Wordliczek J, Zajaczkowska R. Topical clonidine for neuropathic pain in adults. Cochrane Database Syst Rev. 2022 May 19;5(5):CD010967. doi: 10.1002/14651858.CD010967.pub3.
Related trials for Diabetic Neuropathy
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
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.
Judymara L Gozzani, Investigator principal investigator
Santa Casa de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ketamine, ketamine + clonidine and clonidine gel 1% in people with Diabetic Neuropathy and Pain, run by Irmandade da Santa Casa de Misericordia de Sao Paulo at 1 site in Brazil.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judymara L Gozzani, investigator (55-11-3884-0865, gozzani@osite.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain evaluation by visual analogue scale (time frame: 12 weeks). 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 NCT00661063, 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 18 Apr 2008.