Effect of hereditary factors on the analgesic efficacy and side-effects of codeine

Effect of CYP2D6 polymorphism on the analgesic efficacy and side-effects of codeine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005561-23-FI

Enrollment

1000

Registered

2016-01-14

Start date

2016-03-16

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain MedDRA version: 18.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.1 Level: PT Classification code 10036276 Term: Postoperative analgesia System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Panacod Product Name: Panacod Pharmaceutical Form: Tablet Other descriptive name: PARACETAMOL Other descriptive name: CODEINE PHOSPHATE HEMIHYDRATE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing ambulatory surgery at the Jorvi Hospital. Panacod used for postoperative pain. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

Exclusion criteria: Age 70 yrs, ASA > 3, weight < 50 kg, BMI = 40 kg/m2, pregnancy, lactation, allergy to any of the drugs used in the study, previous side-effects with the study drugs, previous addiction problems with chemical substances, ongoing opioid treatmeat, inability to use NRS-scale.

Design outcomes

Primary

Measure	Time frame
Main Objective: What is the relationship between CYP2D6 genotype and the analgesic efficacy and side-effects of codeine in patients undergoing ambulatory surgery;Secondary Objective: With the use of genome wide association methods it will be studied whether heridatary factors will predict the pharmacokinetics and pharmacodynamics of codeine and paracetamol;Primary end point(s):	—

Countries

Finland

Contacts

Public ContactKlaus Olkkola

Klaus Olkkola

klaus.olkkola@helsinki.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026