E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Male and female subjects, at least 18 years of age with a diagnosis of internal haemorrhoids (1° and 2°) confirmed by protoscopic examination and suffering form an uncomplicated and untreated acute attack. |
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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 | 10022577 |
E.1.2 | Term | Internal haemorrhoids |
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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 primary objective is to evaluate the efficacy of E. prostrata Dry Extract tablets compared to placebo in the treatment of internal haemorrhoids (1° and 2°), based on the proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject (cessation of per rectal bleeding defined as the maintenance of bleeding cessation for at least three continuous days after initial "cessation of bleeding") |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate the efficacy of E. prostrata Dry Extract tablets compared to placebo - in the treatment of internal haemorrhoids (1° and 2°), based on the proportion of sujects in each treatment group without recurrence of bleeding (recurrence of bleeding defined as any episode of bleeding after maintenance of bleeding cessation and before the end of 14 days post-treatment). - based on the change in following symptoms as assessed by subject viz. pain, tenesmus, pruritus, anal discharge and following signs as assessed by the investigator viz. congestion, oedema and exudation. - based on the difference between the two treatment groups in overall assessment of disease condition as assessed by the subject. - by comparing the incidences of clinical and laboratory adverse experiences between the two treatment groups. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adult subjects able to understand nature, significance and scope of the clinical trial agreeing to participate in the study by giving written informed consent. • Male or female subjects, at least 18 years of age with a diagnosis of internal haemorrhoids (1° and 2°) confirmed by proctoscopic examination and suffering from an uncomplicated and untreated acute attack (defined as acute onset of per rectal bleeding within 3 days of inclusion into the study, with at least one of the symptoms viz. pain, tenesmus, pruritus and anal discharge). • Except internal haemorrhoids (1° and 2°), the subject is judged to be in general reasonable health, based on medical history, physical examination, and laboratory screening tests, enabling him or her to complete the trial without anticipated serious co-morbid event.
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E.4 | Principal exclusion criteria |
• Pregnant of lactating women. Women in post-partum period of up to 6 weeks will be excluded. • Women of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception (resulting in a failure rate less than 1% per year) during the study therapy and for 4 weeks after the end of study therapy. • Subjects who have been previously enrolled in a study involving E. prostrata Dry Extract. • Subjects with previous history of surgery for anorectal disease (within 5 years) or any other procedures (including but not limited to injection sclerotherapy, rubber band ligation, photo coagulation, cryotherapy etc.) within 2 years. • Subjects who in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained. • Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study. • Subjects with laboratory values falling outside the defined reference values for haemoglobin, total leucocyte count, differential count, bleeding time, clotting time, PT/INR, aPTT/control, platelet count, SGOT, SGPT, alk. phosphatase, total bilirubin, random blood sugar, serum cholesterol, blood urea, serum creatinine and urine routine and microscopic examination. • Treatment with any of the following at inclusion or in the previous one month-venotropic, anticoagulant, and anti-platelet agent. Subjects on aspirin up to 160 mg for cardiovascular indication will not be excluded from the trial. • Treatment with any of the following at inclusion or in the previous one week anti-inflammatory and analgesic agent. • Other chronic medications not being used at a stable dosage for at least 2 weeks. • Subjects who are currently users (including "recreational use") of illicit drugs or with a history of drug abuse within the past 5 years. • Subjects who have donated a unit of blood or plasma or participated in another clinical study with an investigational agent within the last 4 weeks. • Subjects with associated anal fissures, and/or infective anal pathology.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Enpoints: • Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject at day 14 (cessation of per rectal bleeding defined as the maintenance of bleeding cessation for at least three continuous days after initial "cessation of bleeding)
Secondary Endpoints: • Proportion of subjects in each treatment group without recurrence of bleeding (recurrence of bleeding defined as any episode of bleeding after maintenance of bleeding cessation and before the end of 14 days post-treatment). • Change in the following symptoms viz., pain, tenesmus, pruritus and anal discharge as assessed by the subject at day 14 (categorized as none, mild, moderate and severe) •Change in the following objective signs viz., congestion, oedema, and exudation as assessed by the investigator at day 14 (categorized as absent or present) • Change in overall assessment of disease condition as assessed by the subject on a 10 cm Visual Analogue Scale (VAS) at day 14 where 0=Best Ever and 10=Worst Ever.
Safety Endpoints: • Incidences of clinical and laboratory adverse experiences between treatment groups
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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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 | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |