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Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia (PRISE)

13 июля 2026 г. обновлено: Brainfarma Industria Química e Farmacêutica S/A

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

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

348

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Juliana G. Augusto, Clinical Research Manager
  • Номер телефона: 55-11-97677-6726
  • Электронная почта: juliana.augusto@brainfarma.ind.br

Учебное резервное копирование контактов

Места учебы

  • Бразилия
    • Estado de Bahia
      • Salvador, Estado de Bahia, Бразилия, 41680430
        • Рекрутинг
        • Cpec Obras Sociais Irmã Dulce
        • Контакт:
        • Главный следователь:
          • Edson D. M. Júnior, Epidemiologist
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Бразилия, 30575180
        • Рекрутинг
        • Instituto Anima de Extensão Universitária - Unibh
        • Контакт:
        • Главный следователь:
          • Dayane R. F. C, Neurology Residency
      • Vespasiano, Minas Gerais, Бразилия, 33200664
        • Рекрутинг
        • Centro de Ensino Superior de Vespasiano
        • Контакт:
        • Главный следователь:
          • Fernanda C Perreiras, General/Surgical Oncologist
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Бразилия, 59076000
        • Рекрутинг
        • Apec Sociedade Potiguar de Educação E Cultura
        • Контакт:
        • Главный следователь:
          • Marcos L Freitas, Neurologist
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Бразилия, 20231092
        • Рекрутинг
        • Instituto Estadual Do Cerebro Paulo Niemeyer
        • Контакт:
        • Главный следователь:
          • Luiz E. A. Wildemberg, Endocrinologist
    • Santa Catarina
      • Joinville, Santa Catarina, Бразилия, 89202190
        • Рекрутинг
        • Clinica Neurologica e Neurocirurgica de Joinville
        • Контакт:
        • Главный следователь:
          • Alexandre L Longo, Neurologist
      • Palhoça, Santa Catarina, Бразилия, 88137270
        • Рекрутинг
        • Instituto Anima de Extensão Universitária - Unisul
        • Контакт:
        • Главный следователь:
          • Alexandre C Buffon, Anesthesiologist
    • Sergipe
      • Aracaju, Sergipe, Бразилия, 49055480
        • Рекрутинг
        • Fundação de Beneficência Hospital de Cirurgia
        • Контакт:
        • Главный следователь:
          • Alex V. C. França, Gastroenterologist
      • Aracaju, Sergipe, Бразилия, 49072720
        • Рекрутинг
        • Associação Aracajuana Hospital Santa Isabel
        • Контакт:
        • Главный следователь:
          • Alex V. C. França, Gastroenterologist
      • Aracaju, Sergipe, Бразилия, 49075000
        • Рекрутинг
        • Newdata Clinical Research
        • Контакт:
        • Главный следователь:
          • Alex V. C. França, Gastroenterologist
    • São Paulo
      • Bragança Paulista, São Paulo, Бразилия, 12916900
        • Рекрутинг
        • Casa de Nossa Senhora Da Paz Ação Social Franciscana
        • Контакт:
        • Главный следователь:
          • Rafaella S. D. Beltrame, Intensive care
      • Campinas, São Paulo, Бразилия, 1308756
        • Рекрутинг
        • Synvia Campinas
        • Контакт:
          • Hilari R Bonito
          • Номер телефона: 5519993001616
          • Электронная почта: hilary.bonito@synvia.com
        • Главный следователь:
          • Ana Lígia G. M. Germano, Endocrinologist
      • Campinas, São Paulo, Бразилия, 13092108
        • Рекрутинг
        • Trialstar Campinas
        • Контакт:
        • Главный следователь:
          • Márcia S Carvalho, Endocrinologist
      • São Paulo, São Paulo, Бразилия, 01139000
        • Рекрутинг
        • Synvia Clinical Barra Funda
        • Контакт:
        • Главный следователь:
          • Sara C Siqueira, Endocrinologist
      • São Paulo, São Paulo, Бразилия, 03164000
        • Рекрутинг
        • Iscp Sociedade Educacional
        • Контакт:
        • Главный следователь:
          • Matheus A Silva, Neurologist

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

The following criteria must be met for a participant to be included in the study:

  1. Participants of either sex, aged 18 to 75 years.
  2. 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.

  3. 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.
  4. 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).

  5. 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.

Exclusion Criteria:

A positive response to any of the following criteria will exclude the participant from the study:

  1. The presence of pain unrelated to the primary diagnosis of diabetic peripheral neuropathy or postherpetic neuralgia that could interfere with the evaluation.
  2. Any skin condition that potentially alters sensation in the affected dermatome or area of neuropathic involvement, which could interfere with the assessment.
  3. Having undergone neurosurgical therapy for the treatment of neuropathy.
  4. 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).
  5. History of treatment failure or hypersensitivity to pregabalin or gabapentin.
  6. 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.
  7. 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).
  8. History of illicit drug abuse in the past 2 years.

  9. 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).

  10. Being pregnant, breastfeeding, or intending to become pregnant during the study period.
  11. 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.
  12. Having any condition that prevents participation, at the investigator's discretion.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Pregabalin XR: Extended-release pregabalin
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.
Лекарство: Experimental: Pregabalin XR
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.
Лекарство: experimental placebo
experimental placebo
Активный компаратор: Dorene Tabs: Immediate-release pregabalin
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.
Лекарство: Сравнительное плацебо
Сравнительное плацебо
Лекарство: Comparator: Dorene Tabs
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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline
Временное ограничение: 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.
16 weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
To assess improvement in neuropathic pain during treatment.
Временное ограничение: 1 to 12 weeks
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.
1 to 12 weeks
To assess the proportion of participants who experienced significant improvement in neuropathic pain during and at the end of treatment.
Временное ограничение: 1 to 16 weeks
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).
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.
Временное ограничение: 1 to 16 weeks

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.
1 to 16 weeks
Assess the participant's overall perception of change at the end of treatment.
Временное ограничение: Week 16
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.
Week 16
Evaluate the use of rescue medication.
Временное ограничение: 1 to 16 weeks.
Proportion of participants who used rescue medication, frequency of use, dose, and duration, comparing the experimental medication with the comparator.
1 to 16 weeks.

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Safety Outcome: To evaluate the safety of extended-release pregabalin tablets compared with immediate-release pregabalin tablets in participants with diabetic neuropathy or postherpetic neuralgia.
Временное ограничение: 19 weeks.
Incidence rate of serious and non-serious adverse events-both related and unrelated-by treatment group throughout the clinical trial, based on an analysis of data obtained from clinical and physical examinations and laboratory tests.
19 weeks.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Brainfarma Industria Química e Farmacêutica S/A

Следователи

  • Главный следователь: Mariana Ferreira, Sports Nutrition, A2Z CLINICAL - CENTRO DE PESQUISA CLÍNICA, Valinhos, São Paulo 13271130

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

18 июня 2026 г.

Первичное завершение (Оцененный)

1 июня 2027 г.

Завершение исследования (Оцененный)

1 июня 2027 г.

Даты регистрации исследования

Первый отправленный

18 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

13 июля 2026 г.

Первый опубликованный (Действительный)

20 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

20 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

13 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • HYP008-24

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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