A randomized, multi-center, double-blind, parallel-group, multiple-dose study assessing the analgesic efficacy and safety of 3 different doses of GRT0151Y compared to placebo and an active comparator in adults following tonsillectomy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 450

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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