E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Functional ano-rectal pain disorders |
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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 | 10058446 |
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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 study was designed to test safety and efficacy of the novel medication (Antrorect) combining mesalazine 1 g (an anti-inflammatory compound) plus nifedipine 10 mg (a calcium channel blocker effective in relaxing smooth muscle) suppositories in patients with functional ano-rectal pain. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients who have given their free and informed consent. • Male or female patients aged between 18 and 70 years. • A positive diagnosis of functional ano-rectal pain, according to Rome III criteria1. • At least ano-rectal pain once a week in the last 3 months with symptom onset at least 6 months prior to diagnosis (to be confirmed also after the run-in period) • Patients capable of conforming to the study protocol (patient’s diary to be filled in daily) and to co-operate with the treatment. |
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E.4 | Principal exclusion criteria |
• Patients with organic causes of ano-rectal pain such as hemorrhoidal thrombophlebitis, ischemia, IBD, cryptitis, intramuscular abscess, anal fissures, hemorrhoids (III and IV degree), prostatitis, and coccygodynia. First and second degree haemorrhoids do not represent an exclusion criteria. • Patients with previous ano-rectal surgery at least 5 years apart. • Hypersensitivity or allergy to nifedipine, mesalazine, other salicylates (including aspirin), or to any component of the rectal suppositories, including the suppository vehicle. • Pregnancy and breastfeeding as well as females of childbearing potential, in the absence of effective contraceptive methods. • Presence of severe psychiatric disorders (e.g. bipolar disorder, eating disorders, alcohol or drug addiction, etc). • Treatment with any investigational drug within the previous 30 days. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The Primary efficacy variable will be adequate relief from ano-rectal pain (measured by VAS) with the study medication at the end of treatment (as difference by baseline value), in the group treated with Antrorect as compared with placebo. |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | No |
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
|
The end of the study is defined as the last protocol-defined contact of any subject enrolled in the study. If the Investigator prematurely terminates the study, an explanatory letter must be provided to Bracco. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |