Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)

Launched by SIGMOID PHARMA · Dec 15, 2009

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female aged \> 18 years
• • Diagnosis of mild to moderate diagnosis of UC involving at least the rectum and sigmoid colon
• • Clinical severity assessed at screening using the Disease Activity Index (DAI)
• • Clinical severity documented and confirmed by flexible sigmoidoscopy, within 7 days of starting study treatment
• • Signed and dated written informed consent.
• • Willing to maintain current UC medication dosing regimen from screening until the end of the 4-week treatment period.
• • Able and willing to refrain from intake of St. Johns Wort or any other prescription, over-the-counter, or herbal preparation that is known to affect cytochrome P450 metabolism throughout the 4-week treatment period.
• • Able and willing to refrain from intake of grapefruit or grapefruit juice or any other food or drink that is known to affect cytochrome P450 metabolism throughout the 4 week treatment period of the study.
• Exclusion Criteria:
• • Severe or fulminant UC.
• • UC limited to rectum only.
• • Any previous colonic surgery.
• • Any histological evidence of dysplasia on colonoscopic biopsy.
• • Women of childbearing potential who are unable or unwilling to use adequate contraceptive methods to avoid pregnancy.
• • Previous unsuccessful ciclosporin therapy.
• • Biologic therapy within the past 2 months prior to study treatment.
• • Methotrexate therapy within 4 weeks of study treatment.
• • A steroid treatment dose of greater than 10 mg/day prednisolone (or equivalent) within 4 weeks of study treatment.
• • Use of topical treatment (e.g. enemas) within 4 weeks of study treatment and unwilling to refrain from use of topical treatments from the screening visit until the end of the 4-week treatment period.
• • Significant renal impairment, hepatic impairment, uncontrolled hypertension, premalignant skin lesions or current malignancies, or any other severe co-morbid condition.
• • Known hypersensitivity to ciclosporin or any of its excipients.
• • Positive screening stool assay for Clostridium difficile, hemorrhagic E.coli 0157:H7, Salmonella or Shigella
• • Diagnosis of Crohn's colitis, ischemic colitis, NSAID-induced colitis, or radiation colitis.