- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00613197
EPANOVA in Crohn's Disease, Study 1 (EPIC-1)
A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease.
The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI < 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics.
Secondary objectives are to assess the:
efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission
safety and tolerability of Epanova
ability of Epanova to maintain the quality of life of CD patients in remission
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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-
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Leuven, Belgio, 3000
- University of Leuven
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Male or female subject, age 17 or older; country-specific age limitations will be followed
- Diagnosis of Crohn's disease confirmed by radiological studies or endoscopy or surgical pathology within 36 months prior to randomisation
- In remission for at least 3 months, but no longer than 12 months; remission being defined as meeting both of the two conditions: (1) clinically in remission with a CDAI of less than 150 and (2) off steroids and/or immunosuppressants for at least 3 months, if remission had been induced with such medications
Exclusion Criteria:
- Intolerance of omega-3 fatty acids or known allergy to fish or fish products
- Ongoing CD therapy with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, tube feeding, defined formula diets or parenteral nutrition
- In 3 months prior to randomisation received: systemic steroid therapy, azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, probiotic products or preparations containing fish oil
- In 12 months prior to randomisation received: biologicals e.g. enbrel, infliximab, mycophenolate, tacrolimus, thalidomide, other immune modifiers and/or investigational products
- Chronic use of narcotics for pain control (opiates for diarrhoea are acceptable)
- Documented short bowel syndrome, ostomy
- Need for bowel surgery for CD, bowel obstruction or resection in past 3 months (a subject who had a bowel resection in the past must have had at least one relapse after the surgery)
- Malignancy and/or clinically significant impairment in cardiac, liver or renal function, CNS, pulmonary, hematological, immunological, vascular and gastrointestinal disease in addition to CD
- Known alcoholism or drug abuse
- Any medical conditions which, in the investigator's opinion, may interfere with the evaluation of the trial medication
Any of the following laboratory abnormalities:
- White blood count < 3 x 109/L
- Lymphocyte count < 0.5 x 109/L
- Haemoglobin < 80 g/L
- Platelet count < 125 x 109/L or > 800 x 109/L
- ALT or AST > 2.0 times the upper limit of normal
- Alkaline Phosphatase > 2.0 times the upper limit of normal
- Serum Creatinine > 1.5 times the upper limit of normal
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: 2 placebo
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4g/day in divided doses
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Sperimentale: 1 Epanova
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4g/day in divided doses
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
time to clinical relapse
Lasso di tempo: 52 weeks
|
52 weeks
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
CDAI Investigator and subject global rating Quality of life C-reactive protein
Lasso di tempo: 52 weeks
|
52 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Paul Rutgeerts, MD, Prof., University of Leuven
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TP0307
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .