| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Irritable bowel syndrome and functional dyspepsia |
| Síndrome de intestino irritable y dispepsia funcional. |
|
| E.1.1.1 | Medical condition in easily understood language |
| Irritable bowel syndrome and functional dyspepsia |
| Síndrome de intestino irritable y dispepsia funcional. |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10023003 |
| E.1.2 | Term | Irritable bowel syndrome |
| E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10064536 |
| E.1.2 | Term | Functional dyspepsia |
| E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
| 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 determine the effect of STW5 and STW5-II on transit and evacuation of intestinal gas in subjects with functional dyspepsia and irritable bowel syndrome according to Rome IV criteria. |
| Determinar el efecto de STW5 y STW5-II sobre el tránsito y la evacuación del gas intestinal en sujetos con dispepsia funcional y síndrome del intestino irritable, de acuerdo con los criterios de Roma IV. |
|
| E.2.2 | Secondary objectives of the trial |
1. To determine if treatment with STW5 accelerates transit and evacuation of colonic gas, and improves gas tolerance in subjects with irritable bowel syndrome.
2. To determine if treatment with the new formulation STW5-II (Iberogast-N) accelerates transit and evacuation of colonic gas and improves gas tolerance in subjects with irritable bowel syndrome.
3. To determine if treatment with STW5 accelerates transit and evacuation of gastric gas and improves gas tolerance in subjects with functional dyspepsia.
4. To determine if treatment with STW5-II accelerates transit and evacuation of gastric gas, and improves gas tolerance in subjects with functional dyspepsia. |
1. Determinar si el tratamiento con STW5 acelera el tránsito y la evacuación del gas colónico y mejora la tolerancia a los gases en sujetos con síndrome del intestino irritable.
2. Determinar si el tratamiento con la nueva formulación STW5-II acelera el tránsito y la evacuación del gas colónico y mejora la tolerancia a los gases en sujetos con síndrome del intestino irritable.
3. Determinar si el tratamiento con STW5 acelera el tránsito y la evacuación de gas gástrico y mejora la tolerancia a los gases en sujetos con dispepsia funcional.
4. Determinar si el tratamiento con STW5-II acelera el tránsito y la evacuación de gas gástrico y mejora los síntomas de tolerancia a los gases en sujetos con dispepsia funcional. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Subject has read and signed the Institutional Review Board-approved Informed Consent form before Screening.
2. ≥18 years old.
3. Confirmed Irritable Bowel Syndrome (IBS) or Functional Dyspepsia (FD) diagnosis per Rome IV criteria.
4. Has active symptoms of bloating.
5. Subject must be willing to comply with the protocol.
6. Female subjects who are capable of conceiving must use an acceptable form of contraception in order to participate in the study*. |
1. Lectura y firma del consentimiento informado por parte del sujeto antes del screening.
2. Edad mayor o igual a 18 años.
3. Diagnóstico de síndrome de intestino irritable o dispepsia funcional según los criterios Roma IV.
4. Síntomas activos de hinchazón/distensión abdominal.
5. Voluntad del sujeto para cumplir con el protocolo.
6. En mujeres con potencial de procreación, utilizar un método anticonceptivo aceptable*. |
|
| E.4 | Principal exclusion criteria |
1. Presence of any organic gastrointestinal diseases.
2. Subjects with known hypersensitivity to Iberogast or one of the active substances or excipients.
3. One or more medical condition(s), including renal, hepatic, hematologic, endocrinological, neurologic, or immune disease that in the opinion of the Investigator would make the subject an inappropriate candidate for this study.
4. Malignant disease not in remission.
5. Presence of any active infectious disease.
6. Subjects not willing to stop medications that may interfere with gastrointestinal motility during 48 h previous to the gas infusion tests. These include: bulking agents, laxatives, linaclotide, prokinetics, antidiarrheal or opioids.
7. Known alcohol or drug abuse.
8. Female participants of childbearing potential with a positive pregnancy test, breast feeding, or female participants of childbearing potential without adequate contraception.
9. Subject judged by the investigator or study staff to be unable or unlikely to comply with daily protocol requirements, or study visits. |
1. Presencia de cualquier enfermedad gastrointestinal orgánica.
2. Hipersensibilidad conocida a Iberogast® o a cualquiera de sus sustancias activas o excipientes.
3. Una o más condiciones médicas, incluyendo: enfermedad renal, hepática, hematológica, endocrina, neurológica o inmune que, en la opinión del investigador, conviertan al sujeto en un candidato inadecuado para este estudio.
4. Enfermedad maligna no en remisión.
5. Presencia de cualquier enfermedad infecciosa activa.
6. Sujetos que no desean suspender los medicamentos que pueden interferir con la motilidad gastrointestinal durante las 48 h previas a las pruebas de infusión de gas. Estos incluyen: agentes de carga, laxantes, linaclotida, procinética, antidiarreicos u opioides.
7. Abuso conocido de alcohol o drogas.
8. Mujeres en edad fértil con una prueba de embarazo positiva, lactancia o mujeres en edad fértil sin anticoncepción adecuada.
9. Sujeto que, a juicio del investigador o el personal del estudio, sea incapaz o improbable de cumplir con los requisitos diarios del protocolo o las visitas de estudio. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| To compare final gas retention (calculated as total gas infused minus total gas evacuated) after a gas challenge test performed after 2 weeks treatment with Iberogast® or Iberogast® N vs placebo. |
| Comparar la retención final de gas (calculada como gas infundido menos el total de gas evacuado) después de una prueba de provocación de gas después de 2 semanas de tratamiento con Iberogast®, Iberogast® N o placebo. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| After 2 weeks of treatment. |
| Después de 2 semanas de tratamiento. |
|
| E.5.2 | Secondary end point(s) |
To compare the perception of abdominal symptoms induced by the gas challenge test after 2 weeks treatment with Iberogast® or Iberogast® N vs placebo.
To compare the objective abdominal distension (measured by a tape measure) induced by the gas challenge test after 2 weeks treatment with Iberogast® or Iberogast® N vs placebo. |
- Comparar la percepción de síntomas abdominales inducida por la prueba de provocación de gas después de 2 semanas de tratamiento con Iberogast®, Iberogast® N o placebo.
- Comparar la distensión abdominal objetiva (medida por cinta métrica) inducida por la prueba de provocación de gas después de 2 semanas de tratamiento con Iberogast®, Iberogast® N o placebo. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| After 2 weeks of treatment. |
| Después de 2 semanas de tratamiento. |
|
| 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 | No |
| 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 | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
| Effect of treatment on transit and evacuation of intestinal gas. |
| Efecto del tratamient en el tránsito y la evacuación del gas intestinal |
|
| 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) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| 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 | Yes |
| 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 | 5 |
| 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 | 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
|
| Last visit of the last subject |
| Última visita del último paciente. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 7 |
| E.8.9.1 | In the Member State concerned days | |
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