このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

348

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.
薬：experimental placebo
experimental placebo
アクティブコンパレータ：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.
薬：コンパレータプラセボ
コンパレータプラセボ
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
To assess improvement in neuropathic pain during treatment.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.

その他の成果指標

結果測定
メジャーの説明
時間枠
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.
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Brainfarma Industria Química e Farmacêutica S/A

捜査官

  • 主任研究者：Mariana Ferreira, Sports Nutrition、A2Z CLINICAL - CENTRO DE PESQUISA CLÍNICA, Valinhos, São Paulo 13271130

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月18日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年6月1日

試験登録日

最初に提出

2026年6月18日

QC基準を満たした最初の提出物

2026年7月13日

最初の投稿 (実際)

2026年7月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月20日

QC基準を満たした最後の更新が送信されました

2026年7月13日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • HYP008-24

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する