RBR-8h7dmq Study of the analgesic effect of the medication Allopurinol compared to placebo in patients with Fibromyalgia

Date of registration: 09/23/2020 ^(mm/dd/yyyy)
Last approval date : 09/23/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1212-5540

• Public title:

  en

  Study of the analgesic effect of the medication Allopurinol compared to placebo in patients with Fibromyalgia

  pt-br

  Estudo do efeito analgésico da medicação Alopurinol comparado a placebo em pacientes com Fibromialgia

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • CAAE: 229000100007
    Issuing authority: Plataforma Brasil
  • Número do Parecer: 2007-0254
    Issuing authority: Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre

Sponsors

• Primary sponsor: Hospital de Clinicas de Porto Alegre
• Secondary sponsor:
  • Institution: Hospital de Clinicas de Porto Alegre
• Supporting source:
  • Institution: Hospital de Clinicas de Porto Alegre

Health conditions

• Health conditions:

  en

  Fibromyalgia

  pt-br

  Fibromialgia

• General descriptors for health conditions:

  en

  C05 Musculoskeletal Diseases

  pt-br

  C05 Doenças Musculoesqueléticas

• Specific descriptors:

Interventions

• Interventions:

  en

  Patients with fibromyalgia will be randomly allocated to treatment with placebo (Group I, 30 patients) or allopurinol (Group II, 30 patients) with a 4-week follow-up. The treatment will be administered orally, in 2 daily doses (12/12 hours), of allopurinol 300 mg (600 mg / day) or placebo. Patients will undergo assessments of painful sensitivity (verbal pain scale, visual analogue pain scale and simplified McGill scale), anxiety (Trait-State Anxiety Inventory for adults - STAI) and depression (Montgomery-Äsberg scale). A protocol for evaluating demographic data will also be collected. The aforementioned evaluations will be carried out before the start of treatment (baseline evaluation), with 2 and 4 weeks of treatment.

  pt-br

  Os pacientes portadores de fibromialgia serão alocados aleatoriamente para tratamento com placebo (Grupo I, 30 pacientes) ou alopurinol (Grupo II, 30 pacientes) com seguimento de 4 semanas. O tratamento será administrado por via oral, em 2 doses diárias (12/12 horas), de alopurinol 300 mg (600 mg/dia) ou placebo. Os pacientes serão submetidos a avaliações da sensibilidade dolorosa (escala verbal de dor, escala análogo-visual de dor e escala simplificada de McGill), ansiedade (Inventário de Ansiedade Traço-Estado para adultos - IDATE) e depressão (escala de Montgomery-Äsberg). Um protocolo para avaliação de dados demográficos também será coletado. As avaliações supracitadas serão realizadas antes do início do tratamento (avaliação basal), com 2 e 4 semanas de tratamento.

• Descriptors:

  en

  C23.888.592.612 Pain

  pt-br

  C23.888.592.612 Dor

  es

  C23.888.592.612 Dolor

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 03/14/2011 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  60	F	18 Y	65 Y

• Inclusion criteria:

  en

  Female gender; age between 18 and 65 years; functional status class I or II according to the American Society of Anesthesiologists (ASA); patients with fibromyalgia

  pt-br

  Gênero feminino; idade entre 18 e 65 anos; estado funcional classe I ou II de acordo com Sociedade Americana de Anestesiologistas (ASA); portadores de fibromialgia

• Exclusion criteria:

  en

  Previous diagnosis of schizophrenia and other psychotic disorders; history of bipolar disorder; diagnosis of delirium; history of stroke; previous diagnosis of CNS neoplasia; deficit in cognitive or motor development; patients with dialysis renal failure; patients with gout or lithiasic kidney disease; patients who do not understand the Portuguese language or who are illiterate

  pt-br

  Diagnóstico prévio de esquizofrenia e outros transtornos psicóticos; história de distúrbio bipolar; diagnóstico de delirium; história de acidente vascular cerebral; diagnóstico prévio de neoplasia do SNC; déficit de desenvolvimento cognitivo ou motor; portadores de insuficiência renal dialítica; portadores de gota ou nefropatias litiásicas; pacientes que não compreendam a língua portuguesa ou que sejam analfabetos

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  To evaluate the adjuvant analgesic efficacy of oral allopurinol versus placebo associated with conventional treatment in patients with refractory fibromyalgia.

  pt-br

  Avaliar a eficácia analgésica adjuvante do alopurinol por via oral versus placebo associada ao tratamento convencional em pacientes portadores de fibromialgia refratária.

• Secondary outcomes:

  en

  To evaluate the influence of allopurinol compared to placebo in improving symptoms of anxiety and depression associated with fibromyalgia.

  pt-br

  Avaliar a influência do alopurinol comparado ao placebo na melhora de sintomas de ansiedade e depressão associados ao quadro fibromiálgico.

Contacts

• Public contact
  • Full name: André Prato Schmidt
  • • Address: Rua Ramiro Barcelos 2350
    • City: Porto Alegre / Brazil
    • Zip code: 90035-903
  • Phone: +55-51-996412212
  • Email: apschmidtus@yahoo.com
  • Affiliation: Hospital de Clinicas de Porto Alegre
   
• Scientific contact
  • Full name: André Prato Schmidt
  • • Address: Rua Ramiro Barcelos 2350
    • City: Porto Alegre / Brazil
    • Zip code: 90035-903
  • Phone: +55-51-996412212
  • Email: apschmidtus@yahoo.com
  • Affiliation: Hospital de Clinicas de Porto Alegre
   
• Site contact
  • Full name: André Prato Schmidt
  • • Address: Rua Ramiro Barcelos 2350
    • City: Porto Alegre / Brazil
    • Zip code: 90035-903
  • Phone: +55-51-996412212
  • Email: apschmidtus@yahoo.com
  • Affiliation: Hospital de Clinicas de Porto Alegre
   

Additional links:

• Download in ICTRP format