Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
375
Countries
1
Sites
3
Hip fracture
The aim is to investigate how to prevent constipation best after hip surgery using laxatives.
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]
- Trial duration
- 1 Oct 2024 → ongoing
- Decision date (initial)
- 2024-07-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513871-42-00
- EudraCT number
- 2019-003850-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The aim is to investigate how to prevent constipation best after hip surgery using laxatives.
Conditions and MedDRA coding
Hip fracture
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Acute hip fracture surgery patients from one of two orthopedic departments from hospitals in the Southern Region of Denmark. • Age≥ 65 years • The patients should be able to speak and understand Danish
Exclusion criteria 1
- with known chronic constipation (defined from Wexner constipation score) • with known use of laxatives at admission • who participate in other similar clinical studies • who is terminally ill • who is restraint • who is in isolation • with severe heart disease defined as New York Heart Association (NYHA) III og IV • with severe chronically inflammatory bowel disease • with acute abdominal surgical conditions, eg. ileus, obstruction or perforation • with dysphagia where the patient can not swallow tablets/oral liquids • with toxic megacolon • with gastric emptying disorder • with severe electrolyte disorder (P-kalium: < 2.5 mmol/l og P-natrium: <125 mmol/l) • Allergies to the ingredients • Pregnant women can not be included but the women are expected to be postmenopausal why pregnancy test are not performed
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The proportion of patients in each group who needs recue medication after 72 hours or rescue medication before 72 hours on behalf of a medical assessment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP100372675 · ATC
- Active substance
- Simeticone
- Substance synonyms
- ANTIFOAM AF EMULSION, SIMETHICONE, SILICONE S 184, DIMETICONE ACTIVATED, SIMETHICONE ANTIFOAM, ACTIVATED DIMETICONE
- Route of administration
- ORAL
- Max daily dose
- 27.4 g gram(s)
- Max total dose
- 109.6 g gram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- A06AD65 — MACROGOL, COMBINATIONS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP134796 · ATC
- Active substance
- Bisacodyl
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- A06AB02 — BISACODYL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Anton
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Anton
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 375 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-10-01 | 2024-10-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024 513871 42 00 | 2 |
| Protocol (for publication) | D1_Protocol EU CT-no 2024-513871-42-00 | 2 |
| Recruitment arrangements (for publication) | K_Recruiment arrangement | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults EU CT-no 2024-513871-42-00 | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS adult EU CT-no 2024-513871-42-00 | 7.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material information leaflet | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dulcolax | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Gangiden | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-13 | Denmark | Acceptable 2024-07-01
|
2024-07-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-13 | Denmark | Acceptable 2024-07-01
|
2024-08-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-03 | Denmark | Acceptable 2024-07-01
|
2024-09-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-16 | Denmark | Acceptable 2025-07-08
|
2025-07-08 |