An open label study to determine the safety and tolerability oftwo dose escalation treatment regimens with an oral, delayed release preparation of nicotine in patients with stable ulcerative colitismaintained by steroid therapy. - ND
- Conditions
- lcerative colitisMedDRA version: 9.1Level: LLTClassification code 10009900Term: Colitis ulcerative
- Registration Number
- EUCTR2006-006052-35-IT
- Lead Sponsor
- S.L.A. PHARMA (UK) LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
A subject will be considered eligible for this study only if all the following criteria apply: a) Male or female subjects aged 18-65 years who have given written, informed consent.
b) Subjects with a history of mild-to-moderate, left-sided UC extending over at least 15cm and involving the colon and rectum but confirmed at flexible sigmoidoscopy to have no more than low grade inflammation (defined as a Baron score of <=1).
c) Taking stable dose of <=20mg steroid orally per day for at least 4 weeks. (Subjects who are on a stable dose of steroid and who have been taking a stable dose of a 5-aminosalicylic acid product for at least 4 weeks may also be included).
d) Non-smoker or former smoker (abstained >12 months) confirmed at entry by urine cotinine levels.
e) Female subjects of child-bearing potential must be using adequate contraception.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Current immunosuppressant therapy (other than steroid) or within the past 12 weeks. History or evidence on examination of pre-existing cardiac, respiratory, endocrine, renal, liver, neurological or psychiatric disease. Coexisting gastrointestinal disease or previous gut resection. Known hypersensitivity to nicotine or excipients. Pregnant or breastfeeding. Any mental or other impairment which, in the investigator?s opinion would render them unlikely to be able to comply with the requirements of the study. Surgical procedure within the past six months. Participation in a clinical trial within the past three months. Concomitant medication acting on the central nervous, cardiovascular or gastrointestinal system (other than those specified under Section 5.2). Considered by their physician unlikely to be able to comply with the protocol. History of drug or alcohol abuse.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to establish an appropriate dosing schedule that is well-tolerated for oral, delayed-release nicotine capsules in subjects with mild-to-moderate stable UC.;Secondary Objective: To evaluate the safety and tolerability of oral, delayed-release nicotine capsules in subjects with mild-to-moderate stable UC.<br><br>To determine the effects of oral, delayed-release nicotine capsules on faecal calprotectin as a surrogate marker of risk of relapse in subjects with mild-to-moderate stable UC.;Primary end point(s): Number of subjects on each dose level at Day 28. Incidence of adverse events (AEs) during the study.
- Secondary Outcome Measures
Name Time Method