E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relief of complaints associated with hemorrhoids (pain, burning, itching) |
Linderung von Hämorrhoidalleiden (Schmerzen, Brennen, Juckreiz) |
|
E.1.1.1 | Medical condition in easily understood language |
Relief of complaints associated with hemorrhoids (e.g. pain, burning, itching in the anal region) |
Linderung von Hämorrhoidalleiden (wie z.B. Schmerzen, Brennen, Juckreiz im Afterbereich) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10002580 |
E.1.2 | Term | Anorectal therapeutic procedures |
E.1.2 | System Organ Class | 100000004865 |
|
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 |
Proof of superior efficacy of Posterisan® akut mit Lidocain 60 mg/Zäpfchen compared with placebo (vehicle without active substance) in the relief of symptoms associated with hemorrhoids |
Nachweis einer überlegenen Wirksamkeit von Posterisan® akut mit Lidocain 60 mg/Zäpfchen im Vergleich zu einer wirkstofffreien Zäpfchengrundlage (Placebo) in der Linderung von Hämorrhoidalleiden |
|
E.2.2 | Secondary objectives of the trial |
Determining the local tolerability/safety of Posterisan® akut mit Lidocain 60 mg/Zäpfchen in the relief of symptoms associated with hemorrhoids |
Erfassung der lokalen Verträglichkeit/Unbedenklichkeit von Posterisan®akut mit Lidocain 60 mg/Zäpfchen in Linderung von Hämorrhoidalleiden |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- signed informed consent - adults ≥ 18 years - patients with complaints associated with hemorrhoids (pain or burning or itching) - at least one of the symptoms associated with hemorrhoids (pain, burning, itching) hast to be ≥ 65 on the visual analogue scale (VAS): Most bothersome symptom |
- Rechtsgültige Einverständniserklärung zur Studienteilnahme - Alter ≥ 18 Jahre - Patienten mit Hämorrhoidalleiden (Schmerz oder Brennen oder Juckreiz) - Mindestens ein Symptom des Hämorrhoidalleidens (Schmerz, Brennen, Juckreiz) muss auf der visuellen Analogskala (VAS) ≥ 65 eingestuft sein: Leitsymptom |
|
E.4 | Principal exclusion criteria |
- Intra-anal or peri-anal thrombosis - hemorroides grade III and IV - known type IV hypersensitivity - diagnosed rectal carcinoma - diagnosed chronic inflammatory bowel diseases (Morbus Crohn, Colitis ulcerosa) - anorectal infection - use of symptoms' relieving medications (e.g. antihistamines, local anesthetics, analgetics), or in the context of any causal treatment, which could influence the symptoms pain, burning or itching, one week before screening - hypersensitivity against lidocaine or any other substance of the investigational product - known or suggested drug or alcohol abuse - pregnancy and lactation - participation on a clinical trial 12 weeks before screening - committal to an institution due to an official or court order |
- Intraanale oder perianale Thrombosen - Hämorrhoiden Grad III und IV - Fissur - Bekannte Typ IV-Allergie - Bekanntes Rektumkarzinom - Bekannte chronisch entzündliche Darmerkrankungen (M. Crohn, Colitis ulcerosa) - Anorektale Infektion - Einnahme/Anwendung von beschwerdelindernden Medikamenten (z. B.Antihistaminika, Lokalanästhetika, Analgetika) oder im Rahmen einer Kausaltherapie, die die Symptome Schmerz, Brennen oder Juckreiz beeinflussen könnte, eine Woche vor dem Studienbeginn - Überempfindlichkeit gegen Lidocain oder einen der sonstigen Bestandteile des Prüfpräparates - Bekannter oder vermuteter Drogen- oder Alkoholabusus - Schwangerschaft und Stillzeit - Teilnahme an einer klinischen Prüfung 12 Wochen vor dem Studienbeginn - Unterbringung aufgrund behördlicher oder gerichtlicher Anordnung in einer Anstalt |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Improvement (decrease) in the subjective most bothersome symptom (MBS) of hemorrhoids: Difference VAS T0 - VAS T3 |
Vergleich zwischen Verum und Placebo für die Besserung (Abnahme) des Leitsymptoms des Hämorrhoidalleidens: Differenz VAS T0 - VAS T3 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Comparison in the change between verum and placebo in the most bothersome symptom (MBS) an days 1 and 2 (Difference VAS T0 - VAS T1 or T2) - Change in the MBS on days 1, 2 and 3 in comparison to screening (T0) - Subgroup analysis: Improvement in the particular symptom (pain, burning, itching): Difference VAS T0 - VAS T3 - Responders/Non-responders (responders: MBS on VAS ≤ 30 mm) - Evaluation of tolerability by the physician - Evaluation of tolerability by the patient |
- Vergleich zwischen Verum und Placebo für die Besserung (Abnahme) des Leitsymptoms des Hämorrhoidalleidens an den Tagen 1 und 2 (Differenzen: VAS T0 - VAS T1 bzw. 2) - Änderung der Zielvariablen (Leitsymptom) an den Tagen 1, 2, 3 der Anwendung im Vergleich zum Screening (T0) - Subgruppenanalyse: Besserung (Abnahme) der einzelnen Symptome (Schmerz, Brennen, Juckreiz): Differenz VAS T0 - VAS T3 - Responder/Nonresponder (Responder: Leitsymptom auf VAS ≤ 30 mm) - Beurteilung der Verträglichkeit durch den Arzt - Beurteilung der Verträglichkeit durch den Patienten |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1 - 3 (depending on the sec. endpoint) |
Tag 1 - 3 (abhängig vom sek. Endpunkt) |
|
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) | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 11 |
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 | No |
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 last visit of the last subject undergoing the trial |
die letzte Visite des letzten Patienten |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |