Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study

Phase 1

• Conditions: Clinically inactive Ulcerative Colitis at risk of relapse; MedDRA version: 19.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-000330-61-ES
• Lead Sponsor: CHIESI ESPAÑA S.A.U.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-07
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female patients 18 years of age or older.
2. Patients with a diagnosis of left-sided or extended ulcerative colitis at least one year before the screening visit.
3. Patients in clinical remission (Partial Mayo Score Index =2 with no single item >1 and rectal bleeding score = 0) at the screening visit.
4. Patients who had at least one relapse of the disease in the 2 years prior to the screening visit.
5. Patients who, according to the medical history, have FC levels above 250 µg/g of faeces in the 30 days preceding the screening visit confirmed between screening and baseline visit by a central laboratory.
6. Receiving treatment at stable doses of oral 5-aminosalicylate for at least 4 weeks prior to the screening visit.
7. Patients who have signed the informed consent form for participating in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Presence of stoma or prior colon resection.
2. Patients with ulcerative colitis confined to the rectum (15 cm or less from the anal border)
3. Receiving treatment with oral or rectal treatment with systemic corticosteroids, immunomodulating agents [thiopurines (azathioprine and 6-mercaptopurine), methotrexate, calcineurin inhibitors (cyclosporine and tacrolimus)] or biologic treatment in the 12 weeks prior to the screening visit
4. Previous intolerance or toxicity associated with systemic corticosteroids.
5. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) unless are using one or more of the highly effective contraceptive measures* at the screening visit.
6. Presence of any disease for which corticosteroid treatment is contraindicated.
7. Any serious disease or comorbidity.
8. Treatment with nonsteroidal anti-inflammatory drugs during more than 7 consecutive days within the 3 months prior to the screening visit.
9. Patients with 8 years or more after the onset of colitic symptoms without a colonoscopy in the 3 years prior to the screening visit.
10. Patients who received any investigational new drug, or participated in a clinical study within the last 8 weeks.
11. Any other condition that, in the judgment of the Investigator, may prevent a patient from completing all the procedures required or patients who refuse to, or lack the capacity to, provide consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified