E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-Haemorrhoidectomy Pain |
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MedDRA Classification |
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 |
To evaluate the efficacy of 10% metronidazole ointment, applied topically TID in and around the anus, on the reduction of pain following haemorrhoidectomy. |
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E.2.2 | Secondary objectives of the trial |
To evaluate and compare the relief of perianal pain following haemorrhoidectomy, against placebo. To evaluate and compare the experienced pain vs expected pain following haemorrhoidectomy in the treatment and placebo groups. To evaluate and compare overall patient satisfaction with the operation To evaluate and compare the number of analgesics required post-operatively by the treatment and placebo group To compare the time taken to return to work and/or normal activities. To determine the safety and tolerability of 10% metronidazole applied topically TID in and around the anus |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Have Grade 3 or 4 haemorrhoids (external disease with or without significant internal component) Be scheduled for Diathermy Haemorroidectomy with ≥2 quadrant involvement Be medically fit for surgery Subjects must be aged 18 years or over and of the legal age of consent. If female, the subject must not be lactating and must be (a) post-menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use adequate contraception for the duration of the study. Must have provided written informed consent to participate.
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E.4 | Principal exclusion criteria |
Have had surgery to the anus or rectum in the past 8 weeks Suffer from a chronic pain syndrome which requires regular narcotic analgesia Have anal fissures Have diagnosed Crohn’s disease Allergic to metronidazole Are taking any prohibited medication. Deemed mentally incompetent Considered by their physician unlikely to be able to comply with the protocol. Taken part in an experimental drug study in the preceding three months.
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E.5 End points |
E.5.1 | Primary end point(s) |
The difference in pain reduction between patients using 10% metronidazole ointment and those using placebo ointment post-haemorrhoidectomy |
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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 | Yes |
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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
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
| 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
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End of trial will be last patient attendance at Clinic visit 3 (8 weeks follow-up) |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |