E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009900 |
E.1.2 | Term | Colitis ulcerative |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of oral, delayed-release nicotine capsules in subjects with mild-to-moderate stable UC.
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. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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. |
|
E.4 | Principal exclusion criteria |
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メ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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of subjects on each dose level at Day 28. Incidence of adverse events (AEs) during the study. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 2 |