A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00545740Tipo: INTERVENTIONALInicio: 28 de nov de 2007Fin estimado: 5 de mar de 2012

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Males and females =\>18yrs of age.
If female of childbearing potential (FOCP), has demonstrated a negative beta HCG (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol.
An episode of acute diverticulitis that resolved without colonic resection.
Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted.

Criterios de exclusión

Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
Active peptic ulcer disease
History of or current presence of inflammatory bowel disease (IBD)
Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
Allergy or hypersensitivity to aspirin or related compounds
Allergy to radiologic contrast agents
Use of another Investigational product within 30 days of Baseline
Use of antibiotic therapy within 4 weeks of Baseline
Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well as drugs active at the 5HT-receptor or anti-spasmodic agents
Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable
Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis
History of alcohol or other substance abuse within the previous year
Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
Females who are lactating

Intervenciones

drug

SPD476 (1.2g)

1.2g SPD476 once daily (QD) orally

drug

SPD476 (2.4 g)

2.4g SPD476 QD orally

drug

SPD476 (4.8 g)

4.8g SPD476 QD orally

drug

Placebo

QD orally

Ubicaciones

CIMEL

Lanús, Buenos Aires, Argentina

Instituto Gamma

Rosario, Santa Fe Province, Argentina

Hospital Bocalandro

Buenos Aires, Argentina

Hospital Heroes de Malvinas

Buenos Aires, Argentina

GEDYT

Buenos Aires, Argentina

Sanatorio Guemes

Buenos Aires, Argentina

Cibic S.A.

Santa Fe, Argentina

Patrocinadores

PrincipalShire

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