Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
30
Countries
1
Sites
2
Proximal humeral fracture
The main objective of this study is to establish the safety of intraoperative local insertion of Iloprost at the fracture site for bone healing of the proximal humeral fracture.
Key facts
- Sponsor
- Charite Universitaetsmedizin Berlin KöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]
- Trial duration
- 21 Sep 2022 → 12 Feb 2026
- Decision date (initial)
- 2024-11-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Deutsche Forschungsgemeinschaft (DFG)
External identifiers
- EU CT number
- 2024-512468-71-00
- EudraCT number
- 2017-003813-24
- WHO UTN
- U1111-1290-9812
- ClinicalTrials.gov
- NCT04543682
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The main objective of this study is to establish the safety of intraoperative local insertion of Iloprost at the fracture site for bone healing of the proximal humeral fracture.
Secondary objectives 1
- To assess the preliminary efficacy of the treatment on bone healing.
Conditions and MedDRA coding
Proximal humeral fracture
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Ilobone A phase I/IIa, prospective, mono-center, randomized, open labeled, controlled study to assess the safety and efficacy of applying Iloprost locally in the fracture site to promote bone healing in patients with proximal humeral fracture
|
Randomised Controlled | None | group 1: ORIF (PHILOS) + catheter insertion (n=10), Normal saline infusion 2.4 ml over the 1st postoperative 24 hours, Iloprost 0.125 ng/kg/min for 24 hours Group 2: ORIF (PHILOS) + catheter insertion (n=10), Normal saline infusion 2.4 ml over the 1st postoperative 24 hours, Iloprost 0.25 ng/kg/min for 24 hours Group 3: ORIF (PHILOS) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult male or female subjects between 40 to 80 years of age old at the time of screening visit
- Scheduled PHILOS plate for proximal humeral fracture with angle stable plate (3 holes PHILOS plate, synthes) for proximal humerus fracture type 3 or 4 according to Neer classification
- ASA Score score ≤ 2;
- Signed written informed consent;
Exclusion criteria 10
- Immunosuppression due to illness or medication
- Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy
- Known allergies to Iloprost
- Past history of same side proximal humeral fracture or deformity
- Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index < 1)
- Conditions where the effects of Iloprost on platelets might increase the risk of haemorrhage (e.g.active peptic ulcers or intracranial haemorrhage).
- Severe coronary heart disease or unstable angina; myocardial infarction within the last six months; decompensated cardiac failure if not under close medical supervision; severe arrhythmias; suspected pulmonary congestion; cerebrovascular events (e.g., transient ischaemic attack, stroke) within the last 3 months.
- Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
- Pathological or open fracture.
- Polytrauma patient
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Identification of any noxious response or toxicity that has a causal relationship to the treatment. Toxicity shall be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Secondary endpoints 6
- Rate of humeral head necrosis
- Humeral head shaft angle
- Pain assessment (VAS)
- Quality of life (EQ-5D)
- Constant-Murley Score (CMS)
- Disabilities of the Arm, Shoulder and Hand score (DASH)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ilomedin® 20 μg/1 ml, Konzentrat zur Herstellung einer Infusionslösung
PRD393972 · Product
- Active substance
- Iloprost Trometamol
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INFILTRATION
- Authorisation status
- Authorised
- ATC code
- B01AC11 — ILOPROST
- Marketing authorisation
- 42424.00.00
- MA holder
- BAYER VITAL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Charite Universitaetsmedizin Berlin KöR
- Sponsor organisation
- Charite Universitaetsmedizin Berlin KöR
- Address
- Augustenburger Platz 1, Wedding Wedding
- City
- Berlin
- Postcode
- 13353
- Country
- Germany
Scientific contact point
- Organisation
- Charite Universitaetsmedizin Berlin KöR
- Contact name
- Centrum für Muskuloskeletale Chirurgie
Public contact point
- Organisation
- Charite Universitaetsmedizin Berlin KöR
- Contact name
- Centrum für Muskuloskeletale Chirurgie
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 30 | 2 |
| 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 |
|---|---|---|---|---|---|
| Germany | 2022-09-21 | 2026-02-12 | 2022-09-21 | 2025-02-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 30092022_protocol_Ilobone _ SIFU17 _v6_ redacted | 6 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Subject information and informed consent form (for publication) | 30092022_Patienteninformation_Ilobone _SIFU17_ V5_redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Iloprost SMPC | 1 |
| Synopsis of the protocol (for publication) | 30092022_Protocol synopsis_Ilobone_ SIFU17_ v6 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-08 | Germany | Acceptable 2024-10-25
|
2024-11-04 |