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

13. července 2026 aktualizováno: 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

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

348

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: 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.
Lék: experimental placebo
experimental placebo
Aktivní komparátor: 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.
Lék: Srovnávací placebo
Srovnávací placebo
Lék: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
To assess improvement in neuropathic pain during treatment.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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.
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Brainfarma Industria Química e Farmacêutica S/A

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

18. června 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. června 2027

Termíny zápisu do studia

První předloženo

18. června 2026

První předloženo, které splnilo kritéria kontroly kvality

13. července 2026

První zveřejněno (Aktuální)

20. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • HYP008-24

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Klinické studie na Srovnávací placebo

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Podmínky

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