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

2026年7月13日 更新者：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

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

348

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：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.
药品：experimental placebo
experimental placebo
有源比较器：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.
药品：比较安慰剂
比较安慰剂
药品：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
To assess improvement in neuropathic pain during treatment.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.

其他结果措施

结果测量
措施说明
大体时间
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.
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Brainfarma Industria Química e Farmacêutica S/A

调查人员

  • 首席研究员：Mariana Ferreira, Sports Nutrition、A2Z CLINICAL - CENTRO DE PESQUISA CLÍNICA, Valinhos, São Paulo 13271130

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月18日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年6月18日

首先提交符合 QC 标准的

2026年7月13日

首次发布 (实际的)

2026年7月20日

研究记录更新

最后更新发布 (实际的)

2026年7月20日

上次提交的符合 QC 标准的更新

2026年7月13日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HYP008-24

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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