Clonidine for postoperative pain management in patients undergoing spine surgery

2023-505969-80-00 Therapeutic exploratory (Phase II) Ended

Start 5 Sep 2023 · End 12 Mar 2024 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 120
Countries 1
Sites 1

Degenerative spine diseases

To examine analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing elective spine surgery on postoperative opioid consumption

Key facts

Sponsor
Aarhus Universitetshospital
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration
5 Sep 2023 → 12 Mar 2024
Decision date (initial)
2023-08-29
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, Safety

To examine analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing elective spine surgery on postoperative opioid consumption

Secondary objectives 1

  1. To examine analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing elective spine surgery on postoperative opioid consumption, pain intensity and opioid-related side effects

Conditions and MedDRA coding

Degenerative spine diseases

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. Patients scheduled for degenerative spine surgery at Aarhus University Hospital will be included in the study.

Exclusion criteria 11

  1. Age < 18 years
  2. American Society of Anesthesiologists (ASA) physical status IV or V
  3. Allergy to clonidine
  4. Inability to provide informed consent
  5. Known severe renal insufficiency (eGFR < 30)
  6. Known severe bradyarrhythmia
  7. Known severe ischemic heart disease
  8. Known severe congestive heart failure (Ejection Fraction < 30%)
  9. Known severe disseminated cancer disease
  10. Pregnancy and/or lactation
  11. Planned treatment with epidural analgesia, methadone, or infusion of ketamine in the perioperative period

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary outcome is postoperative opioid consumption within the first 3 hours after arrival at the PACU

Secondary endpoints 7

  1. Postoperative opioid consumption within the first 6 hours after arrival at the PACU
  2. Daily opioid consumption after 1 month
  3. Intensity of pain at rest and during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU, measured on a Numeric Rating Scale (NRS, 0-10)
  4. Sedation at 0, 60, and 120 minutes after arrival at the PACU (Ramsey Sedation Score 1-6)
  5. Nausea and/or vomiting at 0, 60, and 120 minutes after arrival at the PACU (yes/no)
  6. Time for discharge from the PACU
  7. Length of hospital stay

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Clotaxip, injektionsvæske, opløsning

PRD9199236 · Product

Active substance
Clonidine Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INFUSION
Max daily dose
3.00 µg/Kg microgram(s)/kilogram
Max total dose
3.00 µg/Kg microgram(s)/kilogram
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
C02AC01 — CLONIDINE
Marketing authorisation
64890
MA holder
2CARE4 GENERICS APS
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Natriumklorid 9 mg/ml "Fresenius Kabi", solvens til parenteralt brug

PRD2503457 · Product

Active substance
Sodium Chloride
Substance synonyms
SODIUM CHLORID, SODIUM CHLORIDE (FOR PH ADJUSTMENT)
Pharmaceutical form
SOLVENT FOR PARENTERAL USE
Route of administration
INFUSION
Max daily dose
2.00 ml millilitre(s)
Max total dose
2.00 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
Marketing authorisation
17927
MA holder
FRESENIUS KABI AB
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 1

Natriumklorid Fresenius Kabi 9 mg/ml

PRD2128220 · Product

Active substance
Sodium Chloride
Substance synonyms
SODIUM CHLORID, SODIUM CHLORIDE (FOR PH ADJUSTMENT)
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
100.00 ml millilitre(s)
Max total dose
100.00 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
B05BB01 — ELECTROLYTES
Marketing authorisation
14043
MA holder
FRESENIUS KABI AB
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aarhus Universitetshospital

4 Total trials 1 Recruiting 3 Ended
Academic / Non-commercial
Sponsor organisation
Aarhus Universitetshospital
Address
Palle Juul-Jensens Boulevard 99
City
Aarhus N
Postcode
8200
Country
Denmark

Scientific contact point

Organisation
Aarhus Universitetshospital
Contact name
Lone Nikolajsen

Public contact point

Organisation
Aarhus Universitetshospital
Contact name
Lone Nikolajsen

Third parties 1

OrganisationCity, countryDuties
Aarhus University
ORG-100028380
 Aarhus N, Denmark On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ended 120 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ended
Region Midtjylland
Department of Anaesthesiology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2023-09-05 2023-09-05 2024-03-12

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

TitleSubmission dateStatusType
Summary of results
SUM-74175
 2025-03-11T13:42:16 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Lay person summary of results 2025-03-11T13:48:31 Submitted Laypersons Summary of Results

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) Summary of results for layperson - CLONISPINE 1
Summary of results (for publication) Summary of results - CLONISPINE 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-06-08 Denmark Acceptable
2023-08-28
 2023-08-29