Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruitment pending
Participants planned
156
Countries
1
Sites
2
Comparison of diagnostic tools
To evaluate and compare the degree of cleaning and visualization of the small intestine mucosa in patients undergoing capsule endoscopy
Key facts
- Sponsor
- Hospital Universitario La Paz
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2025-01-21
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520671-38-00
- EudraCT number
- 2021-000985-14
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis
To evaluate and compare the degree of cleaning and visualization of the small intestine mucosa in patients undergoing capsule endoscopy
Secondary objectives 5
- To establish whether the finding of clinically significant lesions (diagnostic yield) in capsule endoscopy is increased with the use of the preparation
- Quantify gastric transit time (GTT) in different preparation regimens
- Quantifying small bowel transit time (STT) in different preparation regimens
- Investigate patient tolerability and acceptance of different preparations
- Quantify the percentage of completed studies
Conditions and MedDRA coding
Comparison of diagnostic tools
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients aged 18 years or older who are indicated to undergo a small bowel study using capsule endoscopy and whose indication is included in standard clinical practice
- They will provide signed informed consent for performing capsule endoscopy.
- Provide signed and dated informed consent for entry into the clinical trial
Exclusion criteria 7
- Suspected or diagnosed gastrointestinal obstruction/perforation.
- Known small bowel strictures
- Patients with severe gastroparesis
- In case of previous Patency® capsule production: Deformed retention or expulsion of the capsule.
- pregnant
- Patients with severe liver, cardiovascular or kidney disease that contraindicates preparation with polyethylene glycol (Movipep®).
- Patients who present or have presented any adverse reaction or allergy to polyethylene glycol (Moviprep ®) or simethicone.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Degree of small bowel cleansing using an accepted cleansing scale.
Secondary endpoints 6
- Diagnostic yield of capsule endoscopy defined as: finding of clinically significant lesions.
- Gastric transit time (GTT): Defined as the time elapsed from the first gastric image to the first duodenal image. This value will be expressed in minutes.
- Small bowel transit time (STT): This is defined as the time elapsed from the first duodenal image to the first cecal image. When the study does not reach the cecum, the last image of the study will be considered as the first cecal image and it will be indicated that the cecum has not been reached. This value will be expressed in minutes.
- Tolerability of the preparation: Expresses the degree of acceptance or non-acceptance by the patient of the preparation. For this purpose, a questionnaire will be used, which is not validated, and will be completed at the time the capsule is administered.
- Percentage of complete studies: A study is considered complete when it has reached the blind spot during the recording time.
- Other variables: Demographic variables: age, gender, personal history. Reason for requesting capsule endoscopy and diagnosis found. Previous treatment with antiplatelet agents, anticoagulants, non-steroidal anti-inflammatory drugs and/or prokinetics.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Aero-red 100 mg/ml gotas orales en solución
PRD308197 · Product
- Active substance
- Simeticone
- Substance synonyms
- ANTIFOAM AF EMULSION, SIMETHICONE, SILICONE S 184, DIMETICONE ACTIVATED, SIMETHICONE ANTIFOAM, ACTIVATED DIMETICONE
- Pharmaceutical form
- ORAL DROPS, SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 480 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- A03AX13 — SILICONES
- Marketing authorisation
- 39560
- MA holder
- URIACH CONSUMER HEALTHCARE, S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD1849119 · Product
- Active substance
- Ascorbic Acid
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 2 l litre(s)
- Max total dose
- 2 l litre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A06AD — OSMOTICALLY ACTING LAXATIVES
- Marketing authorisation
- 10-7632
- MA holder
- NORGINE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitario La Paz
- Sponsor organisation
- Hospital Universitario La Paz
- Address
- Paseo De La Castellana 261
- City
- Madrid
- Postcode
- 28046
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- Visualization quality and diagnostic performance in smal
Public contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- Visualization quality and diagnostic performance in smal
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 156 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario De Guadalajara SESCAM
DIGESTIVE DISEASE, Calle De Los Donantes De Sangre S/n, 19002, Guadalajara
Hospital Universitario Principe De Asturias
DIGESTIVE DISEASE, Carretera Meco S/n, 28805, Alcala De Henares
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | EC CEI PROYECTO DE INVESTIGACION | 2.0 |
| Recruitment arrangements (for publication) | Reclutamiento | 2.0 |
| Subject information and informed consent form (for publication) | Consentimiento informado | 2.0 |
| Subject information and informed consent form (for publication) | Hoja de informacion al participante | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | Ficha tecnica moviprep | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | ficha tecnica simeticona | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-20 | Spain | Acceptable 2025-01-21
|
2025-01-21 |