Clinical trial • Phase IV • Musculoskeletal

SIMETICONE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS, MACROGOL 4000 for Hip fracture

Phase IV trial of SIMETICONE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS, MACROGOL…. CTIS 2024-513871-42-00.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Hip fracture
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-06-2024
First CTIS Authorization Date
04-07-2024

Trial design

Randomised Phase IV trial across 3 sites in Denmark.

Randomised
Yes
Target Sample Size
375

Eligibility

Recruits 375 Vulnerable population not selected. Participants are adults (Age ≥ 65). Informed consent handled via adult subject information and informed consent forms (documents listed: 'L1_ICF adults EU CT-no 2024-513871-42-00', 'L1_SIS adult EU CT-no 2024-513871-42-00', 'L2_Other subject information material information leaflet'). No assent or paediatric consent procedures described..

Pregnancy Exclusion
Pregnant women can not be included but the women are expected to be postmenopausal why pregnancy test are not performed
Vulnerable Population
Vulnerable population not selected. Participants are adults (Age ≥ 65). Informed consent handled via adult subject information and informed consent forms (documents listed: 'L1_ICF adults EU CT-no 2024-513871-42-00', 'L1_SIS adult EU CT-no 2024-513871-42-00', 'L2_Other subject information material information leaflet'). No assent or paediatric consent procedures described.

Inclusion criteria

  • {"criterion_text":"- • Acute hip fracture surgery patients from one of two orthopedic departments from hospitals in the Southern Region of Denmark.\n- • Age≥ 65 years\n- • The patients should be able to speak and understand Danish"}

Exclusion criteria

  • {"criterion_text":"- with known chronic constipation (defined from Wexner constipation score)\n- with known use of laxatives at admission\n- who participate in other similar clinical studies\n- who is terminally ill\n- who is restraint\n- who is in isolation\n- with severe heart disease defined as New York Heart Association (NYHA) III og IV\n- with severe chronically inflammatory bowel disease\n- with acute abdominal surgical conditions, eg. ileus, obstruction or perforation\n- with dysphagia where the patient can not swallow tablets/oral liquids\n- with toxic megacolon\n- with gastric emptying disorder\n- with severe electrolyte disorder (P-kalium: < 2.5 mmol/l og P-natrium: <125 mmol/l)\n- Allergies to the ingredients\n- Pregnant women can not be included but the women are expected to be postmenopausal why pregnancy test are not performed"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured as the proportion of patients in each group who require rescue medication within the perioperative period (after 72 hours or before 72 hours) as determined by a medical assessment."}

Recruitment

Planned Sample Size
375
Recruitment Window Months
28
Consent Approach
Informed consent obtained using adult subject information and informed consent forms. Documents available include 'L1_ICF adults EU CT-no 2024-513871-42-00' (ICF), 'L1_SIS adult EU CT-no 2024-513871-42-00' (subject information sheet), and 'L2_Other subject information material information leaflet'. Participants must be able to speak and understand Danish; no paediatric assent procedures are described.

Geography

Total Number Of Sites
3
Total Number Of Participants
375

Denmark

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
08-07-2025
Processing Time Days
378
Number Of Sites
3
Number Of Participants
375

Sites

Site Name
Odense University Hospital
Department Name
Othopedic department
Contact Person Name
Mads Suhr Nielsen
Contact Person Email
Mads.Suhr.Nielsen2@rsyd.d
Site Name
Lillebaelt Hospital
Department Name
Othopedic department
Contact Person Name
Ane Simony
Contact Person Email
ane.simony1@rsyd.dk
Site Name
Regional Hospital Horsens
Department Name
Orthopedic department
Contact Person Name
Jeppe Lange
Contact Person Email
jeppe.lange@clin.au.dk

Sponsor

Primary sponsor

Full Name
Odense University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"Codes: 1, 7, 8","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
MACROGOL, COMBINATIONS
Active Substance
SIMETICONE, SODIUM HYDROGEN CARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS, MACROGOL 4000
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number: -
Maximum Dose
27.4 g daily (max total 109.6 g)
Investigational Product Name
BISACODYL
Active Substance
BISACODYL
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Marketing authorisation number: -
Maximum Dose
10 mg daily (max total 20 mg)

Related trials

Other published trials that may interest you.