Neuropathic PainPhase 4NCT01089855
Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain
A Phase 4 study testing Carbamazepine in people with Neuropathic Pain, run by Novartis at 1 site in Morocco.
Trial summary
The trial is designed to evaluate the efficacy and tolerability of carbamazepine in neuropathic pain in diabetic patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Carbamazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteMorocco
- Study dates
- Dec 2009to Jul 2010
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes patients with Diabetes neuropathy DN4 > or equal to 4
- Male or female aged from 21 to 65 years
- Informed consent
- HbA1C < 11%
Who cannot join
- Prior Hospitalization for Acido- cetosis
- Prior hospitalization for severe hypoglycemia
- Pregnancy
- Hepatitis
- Diabetes foot
- AVB (auriculo-ventricular conduction disturbance)
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- Patient treated by antidepressant drugs
- Patient treated with other antiepileptic drug
- Patients with blood ion disturbance
- Patient with neutropenia
- Glaucoma
- Bladder Adenoma
- Alcohol abuse
- Creatinin clearance < 60 ml/ minute
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Open Non Comparative Trial to Evaluate Efficacy and Safety of Tegretol® in Diabetes Neuropathy Pain.
The trial is designed to evaluate the efficacy and tolerability of carbamazepine in neuropathic pain in diabetic patients
- Conditions
- Neuropathic Pain
- Being tested
- Carbamazepine
- Keywords
- Neuropathic Pain, Brief Pain Inventory, DN4 questionnaire, ElectroCardioGram
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbamazepineDrug
| Study group | Role | What they receive |
|---|---|---|
| Carbamazepine | Experimental | Not described Receives: Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)
Measured: 12 weeks
Secondary outcomes (2)
Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding)
Measured: 12 weeks
Evaluate the quality of life
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 posted19 Mar 2010 (estimated)
- Study startDec 2009
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089855
- Sponsor's protocol ID
- CTEG111ZMA01
- Status last verified
- Feb 2011
- First submitted
- 17 Mar 2010
- Last updated
- 13 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Open Non Comparative Trial to Evaluate Efficacy and Safety of Tegretol® in Diabetes Neuropathy Pain.
- ClinicalTrials.gov ID
- NCT01089855
- Acronym / sponsor ID
- CTEG111ZMA01
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic Pain, Brief Pain Inventory, DN4 questionnaire, ElectroCardioGram
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2010 (actual)
- First posted
- 19 Mar 2010 (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 trial is designed to evaluate the efficacy and tolerability of carbamazepine in neuropathic pain in diabetic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbamazepine | Experimental | Drug: Carbamazepine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes patients with Diabetes neuropathy DN4 > or equal to 4
- Male or female aged from 21 to 65 years
- Informed consent
- HbA1C < 11%
Key exclusion criteria (15 listed)
- Prior Hospitalization for Acido- cetosis
- Prior hospitalization for severe hypoglycemia
- Pregnancy
- Hepatitis
- Diabetes foot
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 |
|---|---|---|
| Carbamazepine | Drug | Carbamazepine |
Primary outcome
The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)
Time frame: 12 weeks
2 secondary outcomes
Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding)
Time frame: 12 weeks
Evaluate the quality of life
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 13 Jul 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carbamazepine in people with Neuropathic Pain, run by Novartis at 1 site in Morocco.
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 15 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 13 Jul 2017. 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 Morocco. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI) (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 13 Jul 2017.