Postoperative pain following tonsillectomy MedDRA version: 8.0 Level: LLT Classification code 10054711
Conditions
Interventions
Product Name: GRT0151Y capsule
Pharmaceutical Form: Capsule*
INN or Proposed INN: Axomadol hydrochloride
CAS Number: 187219-95-0
Current Sponsor code: GRT151Y or BN110
Concentration unit: mg milligram
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 65 years inclusive at enrolment and study entry 2. ASA classification I-II 3. Planned bilateral tonsillectomy due to recurrent acute tonsillitis or chronic tonsillitis 4. Anesthesiological and surgical procedures performed according to the protocol 5. Moderate to severe postoperative pain at rest on 4 point VRS and a pain intensity at rest of minimum 4 on 11 point-NRS within 4 hours following the end of the anesthesia 6. Negative urine abuse test at the enrolment visit and pre operative examination. Subjects who declare that they are receiving benzodiazepines for medical purposes may participate even if they test positive. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding mother 2. Evidence or history of neurotic personality, psychiatric illness, epilepsy or suicide risk 3. Women of childbearing potential who does not use satisfactory contraception (i.e. double barrier, hormonal or IUD method) 28 days prior to enrolment visit, during the study and until 28 days after the follow-up visit.) 4. History of chronic hepatitis B or C, or HIV, or presence of active hepatitis B or C within the post 3 months. History of AIDS 5. Poor medical status (e.g. NYHA class = 3; child classification for hepatic impairment >A (Pugh et al., 1973); decompensated chronic obstructive pulmonary disease) or, at the discretion of the investigator, clinical signs that raise concerns about subject’s suitability for the study 6. Creatinine higher than 1.5X upper limit of normal range 7. ALT and/or AST higher than 3X upper limit of normal range 8. At enrolment ECG with findings which could impact operability or any planned study procedure: e.g. marked repolarization abnormality (e.g. suspicious or definite congenital long QT syndrome) and/or QT values of: QTCB females = 450 msec, QTCB males = 430 msec, uncorrected QT = 500 msec pre-operative ECG with findings which could impact operability or any planned study procedure 9. Known contraindications/hypersensitivity to the comparator tramadol and rescue medication acetaminophen or diclofenac 10. Known contraindications/hypersensitivity to opioids or local anesthetics 11. Known coagulation disorder of any etiology 12. Use of anti-coagulants (heparin, warfarin or coumarin derivates) 4 weeks prior to surgery and during the whole treatment period 13. Chronic (=2 weeks) oral intake of corticosteroids less than 2 weeks prior to enrolment 14. Any chronic disease (e.g. hepatic, renal and/or gastrointestinal) that might affect drug absorption, metabolism or excretion 15. Use of analgesics, sedatives or narcotics 12 hours prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the oral multiple-dose analgesic efficacy and safety of 3 different doses of GRT0151Y to placebo in subjects with moderate to severe postoperative pain after tonsillectomy on Day 4 and Day 5;Secondary Objective: 1. To assess the dose-response of 3 different dose levels of GRT0151Y in multiple-dose application in subjects with moderate to severe postoperative pain after tonsillectomy from Day 1 to Day 5. 2. To evaluate the oral multiple-dose analgesic efficacy of 3 different dose levels of GRT0151Y in comparison to Tramadol IR in subjects with moderate to severe postoperative pain after tonsillectomy from Day 1 to Day 5. 3. To evaluate the oral tolerability of multiple-dose of 3 different dose levels of GRT0151Y in comparison to placebo and to Tramadol IR in subjects with moderate to severe postoperative pain after tonsillectomy from Day 1 to Day 5. 4. To assess the time to onset of the analgesic effect of 3 oral dose levels of GRT0151Y on Day 1. 5. To describe the pharmacokinetics of GRT0151Y in the study population from Day 1 to Day 5. ;Primary end point(s): The time averaged pain intensity (TAPI-48) while swallowing on study Days 4 and 5. | — |
Countries
Czech Republic, Finland, Hungary, United Kingdom
Outcome results
None listed