A comparison of the severity of acute pain and the frequency of chronic pain after post-operative analgesia of lower and higher intensity following surgical emptying of the axillary gland in breast cancer patients in relation to the pharmacogenomics in the metabolism of tramadol – a prospective, double blind, randomised clinical trial

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2015-000992-28-SI
• Date of registration: 10/06/2015
• Prospective Registration: Yes
• Primary sponsor: Krka, d.d., Novo mesto
• Public title: A comparison of the severity of acute pain and the frequency of chronic pain after post-operative analgesia of lower and higher intensity following surgical emptying of the axillary gland in breast cancer patients in relation to the pharmacogenomics in the metabolism of tramadol – a prospective, double blind, randomised clinical trial
• Scientific title: A comparison of the severity of acute pain and the frequency of chronic pain after post-operative analgesia of lower and higher intensity following surgical emptying of the axillary gland in breast cancer patients in relation to the pharmacogenomics in the metabolism of tramadol – a prospective, double blind, randomised clinical trial
• Date of first enrolment: 15/07/2015
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000992-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: Use of placebo only in purpose of comparing the lower and higher dosage of Doreta drug. Number of treatment arms in the trial: 2

Countries of recruitment

Slovenia

Contacts

• Name: Clinical Trials Information
• Affiliation: Krka, d.d., Novo mesto

• Name: Clinical Trials Information
• Affiliation: Krka, d.d., Novo mesto

Key inclusion & exclusion criteria

Inclusion criteria:
- Surgical emptying of the axillary gland in breast cancer patients.
- Age of the patients between 18 and 70 years.
- Signed on the voluntary consent of the patient.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
- the simultaneous reconstruction of the breast tissue extender or free lobe;
- hypersensitivity to the drug used in the study (a local anesthetic, piritramide, tramadol, naproxen, acetaminophen, pantoprazole);
- the male gender;
- pregnancy;
- a high risk because of anesthesia (ASA above 3);
- under the age of 18 years and above 70;
- liver and kidney disease;
- participants taking drugs that may have affect on the outcome of treatment (other analgesics, drugs for the treatment of central nervous system);
- the presence of a psychiatric disease (dementia, schizophrenia, manic-depressive illness).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Acute pain after surgical emptying of the axillary gland in breast cancer patients.
MedDRA version: 18.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions

Intervention(s)

Trade Name: Doreta
Product Name: Doreta
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tramadol
Other descriptive name: TRAMADOL HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 37.5-
INN or Proposed INN: paracetamol
Other descriptive name: PARACETAMOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 325-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: The main objective of the trial is the effectiveness of postoperative analgesia of two different doses (with double-blind procedure) of potent combination of tramadol and paracetamol in acute pain intensity.

Primary end point(s): The primary end point of the trial is to determine the effectiveness of postoperative analgesia of two different doses (with double-blind procedure) of potent combination of tramadol and paracetamol in acute pain intensity.

Secondary Objective: - to determine if the expression of genes for the metabolism of tramadol affect on the effectiveness of the treatment of acute pain and on frequency of adverse reactions during the trial
- to compare the performance of postoperative analgesia of two different doses of potent combination of tramadol and paracetamol to prevent the development of chronic pain.

Timepoint(s) of evaluation of this end point: after 28 days of treatment

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: after 28 days of treatment and after 1 year after inclusion into the trial.

Secondary end point(s): The secondary end points of the trial are:
- to determine if the expression of genes for the metabolism of tramadol have affect on the effectiveness of the treatment of acute pain and on frequency of side effects during the tria;l
- to compare the performance of postoperative analgesia of two different doses of potent combination of tramadol and paracetamol to prevent the development of chronic pain.

Secondary ID(s)

KCT04/2015-DORETAonko/SI

Source(s) of Monetary Support

Krka, d.d., Novo mesto