Diabetic Peripheral Neuropathic PainEarly Phase 1NCT05292066
Efficacy of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain at Variable Dose
A Early Phase 1 study testing Duloxetine Tablets, and Pregabalin Tablets in people with Diabetic Peripheral Neuropathic Pain, run by Aga Khan University.
Trial summary
Background Diabetic neuropathy is a widespread, debilitating condition and its management needs a significant cost. Around, 50% of diabetes mellitus (DM) patients suffer from Diabetic Peripheral Neuropathic Pain (DPNP). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- Duloxetine Tablets, and Pregabalin Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 2022
- Phase
- Early Phase 1
- 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
- Both male and female patient with age more than 18 years to 70 years.
- Patients diagnosed with peripheral neuropathic pain affected by diabetes from at least 24 weeks and all other causes off peripheral painful neuropathy has been already excluded by their primary physician.
- Patients who may agree with written inform consent.
- HbA1c ≥ 6.5% and ≤ 10%
Who cannot join
- Patients with severe hepatic disease, cardiovascular diseases, Epilepsy and respiratory diseases or any other medical or psychiatric disorders.
- Patients with uncontrolled hypertension.
- DM patients with foot ulcers, foot injuries or any other painful lesion.
- Patients who are already using or used duloxetine or pregabalin in last three month.
- Pregnant women or those who may not agree to use medical recommended birth control procedures during the treatment.
- Patient with thyroid known disorders or diagnosed during the screening
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- Vitamin B12 deficient patient
- Chronic alcoholics
- DKD, with eGFR < 30ml/min
- Hypertriglycedmia (TGs more then 250mg/dl)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Variable Doses of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain: A Comparative Study
Background Diabetic neuropathy is a widespread, debilitating condition and its management needs a significant cost. Around, 50% of diabetes mellitus (DM) patients suffer from Diabetic Peripheral Neuropathic Pain (DPNP). According to the reported data, specific anticonvulsants and antidepressants are effective for coping diabetic peripheral neuropathy. Two drugs, duloxetine and pregabalin, are officially permitted by the Food and Drug Administration (FDA) for the management of DPNP.
Methodology A Prospective Randomized Controlled Trial (RCT) trial for 12 weeks will be carried out on 126 volunteer DPNP patients with age between 18- to 70-year-old and participants was selected through consecutive sampling and will be evaluated on the basis of duration of the disease, pain scales and the data provided by particular consultants. The parameters will be measured weekly and final parameters will be measured after 12 weeks. Statistical analysis will be carried out by SPSS, ANOVA, and t-test.
Read more
Expected outcomes:
From this experimental design, investigators are expecting improvement in the management of DPNP and Duloxetine is more effective for treating patients suffering from DPNP.
Read the detailed description
This is prospective clinical research, that will be executed from Feb 2022 to May 2022, including, only those patients who are diagnosed with DPNP of at least six months duration, attending Rehman Medical Institute, General hospital. The diagnosis will be primarily clinical.
Randomization of participants will be accomplished by registering the patients into any of two groups (Duloxetine group A, Pregabalin group B) using a statistical computer program. In group A (Duloxetine group) patients will receive duloxetine 30mg/day and group B (Pregabalin group) will receive Pregabalin 75 mg/day for upto 12 weeks.
Biothesiometry will be performed for all diagnosed diabetic patients. Relevant clinical tests like HBA1c, Lipid profile, TSH, vitamin B12 levels will be performed in all patients before randomization.
The sample size was calculated using an open epi sample size calculator using confidence interval 95%, power 80.
Mean ±SD of Duloxetine group was 5.60 ±0.89. Mean ±SD of Pregabalin group was 6.01±0.82. Pregabalin group sample size was calculated to be 63 patients, Duloxetine group sample size was calculated to be 63 patients. Total number of participants was 126.
Only, the approved procedures and protocols will be followed and all patients provided informed consent.
Demographic profiles of volunteer participants like age, gender, living arrangements and others will be noted down. History of disease like duration and treatment for diabetes will be documented. Biothesiometer score above 15 volts will be considered as DNPN. Relevant investigations like HBA1c, Lipid profile, TSH, vitamin B12 levels will be performed in all patients before randomization.
The criteria of classification for DPN will be done on the basis of the proposed TCSS score: zero to five points, without DPN; six to eight points, mild DPN; nine to 11 points, moderate DPN; and 12 to 19 points, severe DPN. The TCSS will be employed in people with type 2 diabetes to assess the prevalence of painful DPNP. A questionnaire (DN-4) will be used to evaluate the pain extent and the adverse effects related to duloxetine and pregabalin will be recorded in all cases.
Toronto clinical neuropathy score (TCNS), consists of three parts: symptom scores, reflex scores, and sensory test scores. The maximum score is 19 points. Better pain relief will be the primary outcome of the proposed study which will be evaluated as a decrease in visual analogue scale (VAS) score.
Written informed consent will be taken from each participant. Patients will be included in the study after informed consent and the patients have the right to withdraw from the trial at any point they want.
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- Duloxetine Tablets,, Pregabalin Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine Tablets,Drug
Also called Cymbalta,
Duloxetine is an FDA-approved medication used to treat the major depressive disorder, generalized anxiety disorder, fibromyalgia, and neuropathic pain. It is taken by mouth. It is a serotonin-norepinephrine reuptake inhibitor.
Pregabalin is an FDA approved, sold under the brand name Lyrica. it is an anticonvulsant and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome,
Pregabalin TabletsDrug
Also called Lyrica.
Pregabalin is an FDA approved, it is an anticonvulsant and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome,
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine Group | Other | Oral intake Duloxetine tablets, 30mg/day for 12 weeks. Receives: Drug: Duloxetine Tablets, |
| Pregabalin Group | Other | Oral intake of Pregabalin tablets, 75 mg/day for 12 weeks. Receives: Drug: Pregabalin Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale score.
Evaluation perceived pain intensity by patients
Measured: 3 months.
Toronto clinical neuropathy score
Final diagnosis and staging of diabetic peripheral neuropathy of patients.
Diabetes severity will be graded according to the results of this score.
Out of a total score of 19, the grades are defined as follows:
0-5 = no neuropathy; 6-8 = mild neuropathy; 9-11 = moderate neuropathy;
≥ 12 = severe neuropathy.
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study startOct 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NASEER AHMED, Rehman Medical Institute - RMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292066
- Sponsor's protocol ID
- 07124
- Status last verified
- Aug 2022
- First submitted
- 9 Feb 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Variable Doses of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain: A Comparative Study
- ClinicalTrials.gov ID
- NCT05292066
- Acronym / sponsor ID
- 07124
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Mar 2022 (actual)
- 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.
Background Diabetic neuropathy is a widespread, debilitating condition and its management needs a significant cost. Around, 50% of diabetes mellitus (DM) patients suffer from Diabetic Peripheral Neuropathic Pain (DPNP). According to the reported data, specific anticonvulsants and antidepressants are effective for coping diabetic peripheral neuropathy. Two drugs, duloxetine and pregabalin, are officially permitted by the Food and Drug Administration (FDA) for the management of DPNP.
Methodology A Prospective Randomized Controlled Trial (RCT) trial for 12 weeks will be carried out on 126 volunteer DPNP patients with age between 18- to 70-year-old and participants was selected through consecutive sampling and will be evaluated on the basis of duration of the disease, pain scales and the data provided by particular consultants. The parameters will be measured weekly and final parameters will be measured after 12 weeks. Statistical analysis will be carried out by SPSS, ANOVA, and t-test.
Expected outcomes:
From this experimental design, investigators are expecting improvement in the management of DPNP and Duloxetine is more effective for treating patients suffering from DPNP.
Detailed description
This is prospective clinical research, that will be executed from Feb 2022 to May 2022, including, only those patients who are diagnosed with DPNP of at least six months duration, attending Rehman Medical Institute, General hospital. The diagnosis will be primarily clinical.
Randomization of participants will be accomplished by registering the patients into any of two groups (Duloxetine group A, Pregabalin group B) using a statistical computer program. In group A (Duloxetine group) patients will receive duloxetine 30mg/day and group B (Pregabalin group) will receive Pregabalin 75 mg/day for upto 12 weeks.
Biothesiometry will be performed for all diagnosed diabetic patients. Relevant clinical tests like HBA1c, Lipid profile, TSH, vitamin B12 levels will be performed in all patients before randomization.
The sample size was calculated using an open epi sample size calculator using confidence interval 95%, power 80.
Mean ±SD of Duloxetine group was 5.60 ±0.89. Mean ±SD of Pregabalin group was 6.01±0.82. Pregabalin group sample size was calculated to be 63 patients, Duloxetine group sample size was calculated to be 63 patients. Total number of participants was 126.
Only, the approved procedures and protocols will be followed and all patients provided informed consent.
Demographic profiles of volunteer participants like age, gender, living arrangements and others will be noted down. History of disease like duration and treatment for diabetes will be documented. Biothesiometer score above 15 volts will be considered as DNPN. Relevant investigations like HBA1c, Lipid profile, TSH, vitamin B12 levels will be performed in all patients before randomization.
The criteria of classification for DPN will be done on the basis of the proposed TCSS score: zero to five points, without DPN; six to eight points, mild DPN; nine to 11 points, moderate DPN; and 12 to 19 points, severe DPN. The TCSS will be employed in people with type 2 diabetes to assess the prevalence of painful DPNP. A questionnaire (DN-4) will be used to evaluate the pain extent and the adverse effects related to duloxetine and pregabalin will be recorded in all cases.
Toronto clinical neuropathy score (TCNS), consists of three parts: symptom scores, reflex scores, and sensory test scores. The maximum score is 19 points. Better pain relief will be the primary outcome of the proposed study which will be evaluated as a decrease in visual analogue scale (VAS) score.
Written informed consent will be taken from each participant. Patients will be included in the study after informed consent and the patients have the right to withdraw from the trial at any point they want.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine Group | Other | Drug: Duloxetine Tablets,Oral intake Duloxetine tablets, 30mg/day for 12 weeks. |
| Pregabalin Group | Other | Drug: Pregabalin TabletsOral intake of Pregabalin tablets, 75 mg/day for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both male and female patient with age more than 18 years to 70 years.
- Patients diagnosed with peripheral neuropathic pain affected by diabetes from at least 24 weeks and all other causes off peripheral painful neuropathy has been already excluded by their primary physician.
- Patients who may agree with written inform consent.
- HbA1c ≥ 6.5% and ≤ 10%
Key exclusion criteria (10 listed)
- Patients with severe hepatic disease, cardiovascular diseases, Epilepsy and respiratory diseases or any other medical or psychiatric disorders.
- Patients with uncontrolled hypertension.
- DM patients with foot ulcers, foot injuries or any other painful lesion.
- Patients who are already using or used duloxetine or pregabalin in last three month.
- Pregnant women or those who may not agree to use medical recommended birth control procedures during the treatment.
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 |
|---|---|---|
| Duloxetine Tablets,Also: Cymbalta,Duloxetine is an FDA-approved medication used to treat the major depressive disorder, generalized anxiety disorder, fibromyalgia, and neuropathic pain. It is taken by mouth. It is a serotonin-norepinephrine reuptake inhibitor. Pregabalin is an FDA approved, sold under the brand name Lyrica. it is an anticonvulsant and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, | Drug | Duloxetine Group |
| Pregabalin TabletsAlso: Lyrica.Pregabalin is an FDA approved, it is an anticonvulsant and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, | Drug | Pregabalin Group |
Primary outcome
visual analogue scale score.
Time frame: 3 months.
Evaluation perceived pain intensity by patients
Toronto clinical neuropathy score
Time frame: 3 months.
Final diagnosis and staging of diabetic peripheral neuropathy of patients. Diabetes severity will be graded according to the results of this score. Out of a total score of 19, the grades are defined as follows: 0-5 = no neuropathy; 6-8 = mild neuropathy; 9-11 = moderate neuropathy; ≥ 12 = severe neuropathy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Duloxetine Tablets, and Pregabalin Tablets in people with Diabetic Peripheral Neuropathic Pain, run by Aga Khan University.
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 10 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 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Dr. Fahim Ullah, MBBS, FCPS (03329142021, drfaheemullah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale score. (time frame: 3 months.). The study lists 2 primary outcomes in all. 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 4 Aug 2022.