Diabetic NeuropathyPhase 3PRISENCT07712913
Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia
A Phase 3 study testing Experimental: Pregabalin XR and Comparator: Dorene Tabs in people with Diabetic Neuropathy and Neuropathic Pain, run by Brainfarma Industria Química e Farmacêutica S/A at 15 sites in Brazil.
Trial summary
Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathy, Neuropathic Pain, Neuralgia, Postherpetic
- What is being tested?
- Experimental: Pregabalin XR and Comparator: Dorene Tabs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 15 sitesBrazil
- Study dates
- 18 Jun 2026to 1 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- The following criteria must be met for a participant to be included in the study:
- Participants of either sex, aged 18 to 75 years.
- Be able to understand and agree to participate in the study, undergo the procedures, and attend the visits, as indicated by signing the informed consent form approved by the CEP/Conep System.
- Have a diagnosis of peripheral neuropathic pain associated with:
- diabetes mellitus (type 1 or 2), with glycated hemoglobin (HbA1c) levels ≤ 11%, documented symptoms of peripheral diabetic neuropathy for at least 6 months, and use of medication for glycemic control at a stable dose for at least 30 days.
- postherpetic neuralgia, with pain symptoms for at least 3 months following a skin rash due to an acute episode of herpes zoster.
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- Presence of neuropathic pain, with an intensity of ≥ 4 on the 11-point DPRS numerical scale (from 0 "no pain" to 10 "worst possible pain"‡). ‡ Pain intensity ≥ 4 will be confirmed at the initial visit (IV); during the screening/randomization visit, Participant Diary No. 1 containing the DPRS scales will be provided, in which the participant will record pain intensity daily upon waking and at the end of the day for 7 days (±2 days). The mean value for pain intensity recorded during the Screening/Randomization Phase will be used to confirm eligibility at the initial visit (IV).
- Participants who are unable to become pregnant (postmenopausal women, defined as 12 months or more of amenorrhea, or who have undergone surgical sterilization*; and men who have undergone vasectomy) OR participants of reproductive potential who agree to use a reliable method of contraception*.
- Female sterilization (undergoing bilateral surgical oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks prior to administration of the investigational drug.
- Male sterilization at least 6 months prior to screening. *** If the participant is of childbearing age and decides to participate in the study, they must use or request that their partner use a safe contraceptive method. A safe contraceptive method is defined as the use of at least one of the following: condoms, a diaphragm, and/or a hormonal method (estrogenic and/or progestogenic) in the form of medication, including oral, vaginal, injectable, transdermal, and intrauterine devices. Only participants who expressly declare themselves exempt from the risk of pregnancy-whether because they do not engage in sexual activity or because they engage in it in a non-reproductive manner-will have the right to participate in the study without the mandatory use of contraceptives. Examples include participants who have undergone a vasectomy, those with an infertile partner, or those practicing total heterosexual abstinence.
- The decision regarding the best contraceptive method to use will be made jointly by the physician and the study participant. If there are any costs involved, the chosen contraceptive method will be provided by the sponsor free of charge for as long as necessary. In addition, condoms with spermicide will be provided to participants at all study visits, when applicable.
Who cannot join
- A positive response to any of the following criteria will exclude the participant from the study:
- The presence of pain unrelated to the primary diagnosis of diabetic peripheral neuropathy or postherpetic neuralgia that could interfere with the evaluation.
- Any skin condition that potentially alters sensation in the affected dermatome or area of neuropathic involvement, which could interfere with the assessment.
- Having undergone neurosurgical therapy for the treatment of neuropathy.
- Current use, or use within the past 7 days, of nerve block therapy and/or medications commonly used to treat neuropathic pain (e.g., benzodiazepines, skeletal muscle relaxants, capsaicin, local anesthetics, opioids, memantine), antiepileptic drugs (e.g., carbamazepine, clonazepam, phenytoin, valproic acid, lamotrigine, topiramate, gabapentin), antidepressants (e.g., tricyclics, serotonin reuptake inhibitors, venlafaxine), and potential neurotoxins (e.g., hydroxychloroquine, deferoxamine, thioridazine, vigabatrin).
- History of treatment failure or hypersensitivity to pregabalin or gabapentin.
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- History of neoplastic disease within the past 2 years (excluding basal cell carcinoma), neurological disease, unstable heart disease, psychiatric conditions (particularly suicidal ideation), and/or infection with hepatitis B, hepatitis C, or HIV.
- Current laboratory abnormalities in liver enzymes (elevated AST and/or ALT 2.5 times the upper limit of the reference range) and/or renal insufficiency (glomerular filtration rate < 60 mL/min/1.73 m²).
- History of illicit drug abuse in the past 2 years.
- History of alcoholism (average alcohol intake exceeding 3 standard drinks* per day or more than 7 standard drinks per week for women, and exceeding 4 standard drinks per day or more than 14 standard drinks per week for men) in the past 2 years.
- A standard drink is: a can of regular beer (330 mL at 4%); a shot of distilled spirits (30 mL at 40%); a glass of wine or a small glass of sherry (100 mL at 12% or 70 mL at 18%); a small glass of liqueur or similar (50 mL at 25%) (53).
- Being pregnant, breastfeeding, or intending to become pregnant during the study period.
- Having participated in clinical studies in the past 12 (twelve) months, unless there may be a direct benefit to the study participant, at the investigator's discretion.
- Having any condition that prevents participation, at the investigator's discretion.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Juliana G. Augusto, Clinical Research Manager contact
Juliana A. L. Antonio, Scientific Documentation Coord contact
15 sites in 1 country
Brazil15 sites, 15 recruiting
- Recruiting
Fundação de Beneficência Hospital de Cirurgia
Aracaju, Sergipe, 49055480
Katiane Soares Research Center Manager, 5511970306077, katiane.soares@newdatatrials.com
Alex V. C. França, Gastroenterologist
- Recruiting
Associação Aracajuana Hospital Santa Isabel
Aracaju, Sergipe, 49072720
Katiane Soares Research Center Manager, 5511970306077, katiane.soares@newdatatrials.com
Alex V. C. França, Gastroenterologist
- Recruiting
Newdata Clinical Research
Aracaju, Sergipe, 49075000
Katiane Soares Research Center Manager, 5511970306077, katiane.soares@newdatatrials.com
Alex V. C. França, Gastroenterologist
- Recruiting
Instituto Anima de Extensão Universitária - Unibh
Belo Horizonte, Minas Gerais, 30575180
Tatiane C B, 5531982858977, tatiane.cristine@animaeducacao.com.br
Dayane R. F. C, Neurology Residency
- Recruiting
Casa de Nossa Senhora Da Paz Ação Social Franciscana
Bragança Paulista, São Paulo, 12916900
Larissa Germana Silva, 5511972076829, larissa.germana@unifag.com.br
Rafaella S. D. Beltrame, Intensive care
- Recruiting
Synvia Campinas
Campinas, São Paulo, 1308756
Hilari R Bonito, 5519993001616, hilary.bonito@synvia.com
Ana Lígia G. M. Germano, Endocrinologist
- Recruiting
Trialstar Campinas
Campinas, São Paulo, 13092108
Natasha Scavone, 5511934217295, natasha.scavonek@outlook.com
Márcia S Carvalho, Endocrinologist
- Recruiting
Clinica Neurologica E Neurocirurgica de Joinville
Joinville, Santa Catarina, 89202190
Ana Paula O. P. Pires, 5547999048082, centrodepesquisaavc@neurologica.com.br
Alexandre L Longo, Neurologist
- Recruiting
Apec Sociedade Potiguar de Educação E Cultura
Natal, Rio Grande do Norte, 59076000
Maynara Caroline, 5584988852274, maynara.gabriel@inspirali.com
Marcos L Freitas, Neurologist
- Recruiting
Instituto Anima de Extensão Universitária - Unisul
Palhoça, Santa Catarina, 88137270
Bruna K Coelho, 5549988118267, bruna.kellet@animaeducacao.com.br
Alexandre C Buffon, Anesthesiologist
- Recruiting
Instituto Estadual Do Cerebro Paulo Niemeyer
Rio de Janeiro, Rio de Janeiro, 20231092
Charles R Seixas, 5521967075993, charleseixas.cpc@gmail.com
Luiz E. A. Wildemberg, Endocrinologist
- Recruiting
Cpec Obras Sociais Irmã Dulce
Salvador, Estado de Bahia, 41680430
Tâmara T. C. Marocci, 557134835365, tamara.marocci@irmadulce.org.br
Edson D. M. Júnior, Epidemiologist
- Recruiting
Synvia Clinical Barra Funda
São Paulo, São Paulo, 01139000
Giovana M Berbel, 19994891366, giovana.berbel@synvia.com
Sara C Siqueira, Endocrinologist
- Recruiting
Iscp Sociedade Educacional
São Paulo, São Paulo, 03164000
Pedro A M, 5511949041252, pedro.moyano@inspirali.com
Matheus A Silva, Neurologist
- Recruiting
Centro de Ensino Superior de Vespasiano
Vespasiano, Minas Gerais, 33200664
Bruna Paola V Fonseca, 5531995149056, bruna.vilela@animaeducacao.com.br
Fernanda C Perreiras, General/Surgical Oncologist
About this study
Official title: A Phase III, Multicenter, Randomized, Double-blind, Double-dummy, Controlled, Parallel-group, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of Extended-release Pregabalin Tablets Compared With Immediate-release Pregabalin Tablets, in the Relief of Neuropathic Pain in Participants With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia.
Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia
- Being tested
- Experimental: Pregabalin XR, Comparator: Dorene Tabs, Comparator placebo, experimental placebo
- Keywords
- multicenter, randomized, double-blind, double-dummy, controlled, parallel-group, non-inferiority, diabetic, postherpetic neuralgia, peripheral neuropathy, Pregabalin
- Medical subject headings
- Diabetic Neuropathies, Neuralgia, Neuralgia, Postherpetic, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Pregabalin XRDrug
Pregabalin XR: extended-release tablet, with an initial dose of 82.5 mg once daily. The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 660 mg once daily. In addition, the experimental group will receive a placebo twice daily.
Comparator: Dorene TabsDrug
Pregabalin immediate-release tablets, at an initial dose of 75 mg twice daily. The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 300 mg twice daily. In addition, the comparator group will receive a placebo once daily.
Comparator placeboDrug
Comparator placebo
experimental placeboDrug
experimental placebo
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin XR: Extended-release pregabalin | Experimental | Pregabalin XR: will receive extended-release pregabalin tablets at an initial dose of 82.5 mg once daily (during the first week for titration). The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 660 mg once daily. In addition, the experimental group may receive a placebo twice daily. Receives: Drug: Experimental: Pregabalin XR; Drug: experimental placebo |
| Dorene Tabs: Immediate-release pregabalin | Active comparator | Dorene Tabs: will receive immediate-release pregabalin tablets (Dorene Tabs) at a starting dose of 75 mg twice daily. The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 300 mg twice daily. In addition, the comparison group will receive a placebo once daily. Receives: Drug: Comparator: Dorene Tabs; Drug: Comparator placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline
Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline, between the study drug and the comparator, as measured by the 11-point DPRS (Daily Pain Rating Scale) (ranging from 0 "no pain" to 10 "worst possible pain").
Participants completed the baseline scale at the research center and filled it out daily at home until visit V8, twice a day. The average number of scales will be calculated by dividing the number of scales completed by the number of days on which they were completed.
Measured: 16 weeks
Secondary outcomes (5)
To assess improvement in neuropathic pain during treatment.
Difference in the mean pain intensity score at 1, 4, 8, and 12 weeks after the start of treatment, compared to baseline, between the experimental drug and the comparator, as measured by the 11-point DPRS scale.
Measured: 1 to 12 weeks
To assess the proportion of participants who experienced significant improvement in neuropathic pain during and at the end of treatment.
Difference in the mean total pain score at 1, 4, 8, 12, and 16 weeks after the start of treatment, compared to baseline, between the experimental drug and the comparator, as measured by the SF-MPQ (Short Form - McGill Pain Questionnaire).
Measured: 1 to 16 weeks
To assess improvements in the impact of neuropathic pain on sleep, quality of life, and symptoms of anxiety and depression during and at the end of treatment.
Proportion of participants with a ≥ 30% reduction in pain intensity at 1, 4, 8, 12, and 16 weeks after the start of treatment, compared to baseline, between the study drug and the comparator, as measured by the 11-point DPRS scale. Difference in the mean score for pain interference with sleep at 4, 8, 12, and 16 weeks after the start of treatment, relative to baseline, between the study drug and the comparator, as measured by the 11-point DSIS (Daily Sleep Interference Scale) (ranging from 0 "pain did not interfere with sleep" to 10 "pain completely interfered with sleep").
Difference in quality of life at 4, 8, 12, and 16 weeks after the start of treatment, compared to baseline, between the experimental drug and the comparator, as measured by the WHOQoL-BREF (World Health Organization Quality of Life Scale).
Difference in anxiety and depression symptoms at 4, 8, 12, and 16 weeks after the start of treatment, compared to baseline, between the experimental drug and the comparator.
Measured: 1 to 16 weeks
Assess the participant's overall perception of change at the end of treatment.
Proportion of participants who rated their clinical condition as "much better," "moderately better," "slightly better," "no change," "slightly worse," "moderately worse," and "much worse," using the PGIC (Patient Global Impression of Change) scale, when comparing the experimental drug to the comparator 16 weeks after the start of treatment.
Measured: Week 16
Evaluate the use of rescue medication.
Proportion of participants who used rescue medication, frequency of use, dose, and duration, comparing the experimental medication with the comparator.
Measured: 1 to 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start18 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- A multicenter, double-blind, double-dummy, parallel-group study with two treatment groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariana Ferreira, Sports Nutrition, Principal investigator, A2Z CLINICAL - CENTRO DE PESQUISA CLÍNICA, Valinhos, São Paulo 13271130
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712913
- Sponsor's protocol ID
- HYP008-24
- Acronym
- PRISE
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-blind, Double-dummy, Controlled, Parallel-group, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of Extended-release Pregabalin Tablets Compared With Immediate-release Pregabalin Tablets, in the Relief of Neuropathic Pain in Participants With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia.
- ClinicalTrials.gov ID
- NCT07712913
- Acronym / sponsor ID
- PRISE / HYP008-24
- Keywords
- multicenter, randomized, double-blind, double-dummy, controlled, parallel-group, non-inferiority, diabetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 20 Jul 2026 (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.
Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A multicenter, double-blind, double-dummy, parallel-group study with two treatment groups
| Arm | Type | Receives |
|---|---|---|
| Pregabalin XR: Extended-release pregabalin | Experimental | Drug: Experimental: Pregabalin XR, Drug: experimental placeboPregabalin XR: will receive extended-release pregabalin tablets at an initial dose of 82.5 mg once daily (during the first week for titration). The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 660 mg once daily. In addition, the experimental group may receive a placebo twice daily. |
| Dorene Tabs: Immediate-release pregabalin | Active comparator | Drug: Comparator: Dorene Tabs, Drug: Comparator placeboDorene Tabs: will receive immediate-release pregabalin tablets (Dorene Tabs) at a starting dose of 75 mg twice daily. The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 300 mg twice daily. In addition, the comparison group will receive a placebo once daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants of either sex, aged 18 to 75 years.
- Be able to understand and agree to participate in the study, undergo the procedures, and attend the visits, as indicated by signing the informed consent form approved by the CEP/Conep System.
- Have a diagnosis of peripheral neuropathic pain associated with:
- Presence of neuropathic pain, with an intensity of ≥ 4 on the 11-point DPRS numerical scale (from 0 "no pain" to 10 "worst possible pain"‡). ‡ Pain intensity ≥ 4 will be confirmed at the initial visit (IV); during the screening/randomization visit, Participant Diary No. 1 containing the DPRS scales will be provided, in which the participant will record pain intensity daily upon waking and at the end of the day for 7 days (±2 days). The mean value for pain intensity recorded during the Screening/Randomization Phase will be used to confirm eligibility at the initial visit (IV).
- Participants who are unable to become pregnant (postmenopausal women, defined as 12 months or more of amenorrhea, or who have undergone surgical sterilization*; and men who have undergone vasectomy) OR participants of reproductive potential who agree to use a reliable method of contraception*.
Key exclusion criteria (14 listed)
- A positive response to any of the following criteria will exclude the participant from the study:
- The presence of pain unrelated to the primary diagnosis of diabetic peripheral neuropathy or postherpetic neuralgia that could interfere with the evaluation.
- Any skin condition that potentially alters sensation in the affected dermatome or area of neuropathic involvement, which could interfere with the assessment.
- Having undergone neurosurgical therapy for the treatment of neuropathy.
- Current use, or use within the past 7 days, of nerve block therapy and/or medications commonly used to treat neuropathic pain (e.g., benzodiazepines, skeletal muscle relaxants, capsaicin, local anesthetics, opioids, memantine), antiepileptic drugs (e.g., carbamazepine, clonazepam, phenytoin, valproic acid, lamotrigine, topiramate, gabapentin), antidepressants (e.g., tricyclics, serotonin reuptake inhibitors, venlafaxine), and potential neurotoxins (e.g., hydroxychloroquine, deferoxamine, thioridazine, vigabatrin).
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 |
|---|---|---|
| Experimental: Pregabalin XRPregabalin XR: extended-release tablet, with an initial dose of 82.5 mg once daily. The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 660 mg once daily. In addition, the experimental group will receive a placebo twice daily. | Drug | Pregabalin XR: Extended-release pregabalin |
| Comparator: Dorene TabsPregabalin immediate-release tablets, at an initial dose of 75 mg twice daily. The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 300 mg twice daily. In addition, the comparator group will receive a placebo once daily. | Drug | Dorene Tabs: Immediate-release pregabalin |
| Comparator placeboComparator placebo | Drug | Dorene Tabs: Immediate-release pregabalin |
| experimental placeboexperimental placebo | Drug | Pregabalin XR: Extended-release pregabalin |
Primary outcome
Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline
Time frame: 16 weeks
Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline, between the study drug and the comparator, as measured by the 11-point DPRS (Daily Pain Rating Scale) (ranging from 0 "no pain" to 10 "worst possible pain"). Participants completed the baseline scale at the research center and filled it out daily at home until visit V8, twice a day. The average number of scales will be calculated by dividing the number of scales completed by the number of days on which they were completed.
5 secondary outcomes
To assess improvement in neuropathic pain during treatment.
Time frame: 1 to 12 weeks
To assess the proportion of participants who experienced significant improvement in neuropathic pain during and at the end of treatment.
Time frame: 1 to 16 weeks
To assess improvements in the impact of neuropathic pain on sleep, quality of life, and symptoms of anxiety and depression during and at the end of treatment.
Time frame: 1 to 16 weeks
Assess the participant's overall perception of change at the end of treatment.
Time frame: Week 16
Evaluate the use of rescue medication.
Time frame: 1 to 16 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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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.
Juliana G. Augusto, Clinical Research Manager contact
Juliana A. L. Antonio, Scientific Documentation Coord contact
Mariana Ferreira, Sports Nutrition principal investigator
A2Z CLINICAL - CENTRO DE PESQUISA CLÍNICA, Valinhos, São Paulo 13271130
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: Pregabalin XR and Comparator: Dorene Tabs in people with Diabetic Neuropathy and Neuropathic Pain, run by Brainfarma Industria Química e Farmacêutica S/A at 15 sites 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 11 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliana G. Augusto, Clinical Research Manager (55-11-97677-6726, juliana.augusto@brainfarma.ind.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline (time frame: 16 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 20 Jul 2026.