Overview
Sponsor-declared trial summary
Screening patients
The overall object of this project is to investigate Remimazolam with Fentanyl compared to Midazolam with Fentanyl for sedation in screening colonoscopy with the primary outcome being total time from start of medication to fulfillment of the discharge criteria. In this way we will examine whether Remimazolam with Fenta…
Key facts
- Sponsor
- Herlev Hospital
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 25 Aug 2023 → 23 Dec 2023
- Decision date (initial)
- 2023-04-05
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The overall object of this project is to investigate Remimazolam with Fentanyl compared to Midazolam with Fentanyl for sedation in screening colonoscopy with the primary outcome being total time from start of medication to fulfillment of the discharge criteria. In this way we will examine whether Remimazolam with Fentanyl could create an improvement in procedural sedation by leading to both a shorter procedure as well as shorter recovery time.
Conditions and MedDRA coding
Screening patients
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age over 18
- Scheduled for elective colonoscopy screening for colon cancer
- Must be able to provide informed written consent.
Exclusion criteria 2
- Requiring general anesthesia.
- Allergy to Midazolam, Remimazolam, opioids or ingredients.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Total time from start of medication to fulfillment of the discharge criteria
Secondary endpoints 8
- Need for postprocedural recovery room, due to lack of fulfillment of discharge criteria.
- Patient discomfort/pain rated using NRS-11.
- Time to reach coecum.
- Need for additional Fentanyl.
- Need for additional sedativa.
- Patient satisfaction.
- Endoscopist satisfaction
- Cognitive function at discharge.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Midazolam hameln 5 mg/ml raztopina za injiciranje/infundiranje
PRD10070489 · Product
- Active substance
- Midazolam Hydrochloride
- Substance synonyms
- TAK-815, SHP-615, MIDAZOLAM HCL
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 7.5 mg milligram(s)
- Max total dose
- 7.5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CD08 — MIDAZOLAM
- Marketing authorisation
- H/22/02911/041
- MA holder
- HAMELN PHARMA GMBH
- MA country
- Slovenia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Byfavo 20 mg powder for solution for injection
PRD10016502 · Product
- Active substance
- Remimazolam
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CD14 — -
- Marketing authorisation
- EU/1/20/1505/001
- MA holder
- PAION DEUTSCHLAND GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
PRD3238592 · Product
- Active substance
- Fentanyl Citrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4 µg/Kg microgram(s)/kilogram
- Max total dose
- 4 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH01 — FENTANYL
- Marketing authorisation
- 31515
- MA holder
- HAMELN PHARMA GMBH
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Herlev Hospital
- Sponsor organisation
- Herlev Hospital
- Address
- Borgmester Ib Juuls Vej 1
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Herlev Hospital
- Contact name
- Andrea Ambrecht
Public contact point
- Organisation
- Herlev Hospital
- Contact name
- Andrea Ambrecht
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 200 | 1 |
| 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 | 2023-08-25 | 2023-12-23 | 2023-08-28 | 2023-12-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Results from trial SUM-131894
|
2026-05-01T13:11:02 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay | 2026-05-01T13:15:16 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay summary | 1 |
| Summary of results (for publication) | Remimazolam Accepted Manuscript PDF | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-21 | Denmark | Acceptable 2023-04-05
|
2023-04-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-07-11 | Denmark | Acceptable 2023-08-24
|
2023-08-28 |