Placebo-controlled double-blind trial of the analgesic effect and safety of clonidine in patients after major abdominal surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Esbjerg Og Grindsted Sygehus

Participant type

Patients

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]

Decision date (initial)

2024-12-17

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: Pharmacodynamic

The relationship between a single iv. bolus dose of clonidine administered postoperatively to patients undergoing colectomy and postoperative acute pain.

Conditions and MedDRA coding

Trial participants are having colectomy due to cancer

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • Planned colectomy due to cancer. • Age over 18 years. • Able to read and understand Danish. • Willingness and able to comply with scheduled visit, treatment plan, laboratory tests and other trial procedures.

Exclusion criteria 1

1. • Sick sinus syndrome. • Second- or third-degree atrioventricular block. • Known hypersensitivity, intolerance or allergy towards clonidine or morphine. • Clinically relevant side effects or symptoms of allergy, judged by the investigator. • Pregnancy (positive urine HCG)/ lactating. • Participants with any clinical abnormalities that, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of the trial results • Participation in other clinical studies less than six month prior to inclusion. • Hypotension (persistent systolic blood pressure below 100 mmHg). • Bradycardia (< 50 beats/minute). • Known significant decreased kidney function, or an eGFR below 30 ml/min. • Use of a α-agonist drug. (Clonidine, Dexmedetomidine, Tizanidine). • Use of a α-adrenoceptor blocking drug. (Phentolamine, Tolazoline, Phenoxybenzamine, Prazosin, Terazosin, Doxazosin, Alfuzosin, Bunazosin, Tamsulosin, Silodosin, Yohimbine, Idazoxan, Ergot alkaloids).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Use of morphine 24 hours post-operatively

Secondary endpoints 1

1. VAS/NRS (pain scores), Qestionnaires, QST (Quantitative Sensory Testing), ANS (BP, ECG, HR, Sat, Tp, Pupil reaction), Certain genetic profile (CYP2D6, OPRM and COMT sequenced. SNPs of ABCB1 and rs2952768/CREB1 and ncRNA), Blood samples (concentrations of clonidine, morphine, morphine-3-glucoronide, morphine-6-glucoronide), Demographics, physical, medical, laboratory data, Physical examination.

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Esbjerg Og Grindsted Sygehus

Sponsor organisation

Esbjerg Og Grindsted Sygehus

Address

Finsensgade 35

City

Esbjerg

Postcode

6700

Country

Denmark

Scientific contact point

Organisation

Esbjerg Og Grindsted Sygehus

Contact name

Clinical trial information desk c/o department of Anesthesiology

Public contact point

Organisation

Esbjerg Og Grindsted Sygehus

Contact name

Clinical trial information desk c/o department of Anesthesiology

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

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

Application history

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