A randomized, multi-centre, double blind, parallel-group study assessing the analgesic efficacy and safety of different dosages of GRT0151Y bid compared to active comparator bid and placebo bid in subjects with chronic knee-joint osteoarthritis

• Conditions: Osteoarthritis of the knee; MedDRA version: 8.0Level: LLTClassification code 10023476

• Registration Number: EUCTR2005-003360-26-DE
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

- Males or non-pregnant, non-lactating females. Female subjects of childbearing potential must use an acceptable method of contraception (i.e. hormonal method, IUD or double barrier) during the study period and have a negative urine pregnancy test (at enrolment and at day 1)
- 40-70 years of age
- No clinical relevant abnormalities of laboratory parameters taken at enrolment visit
- Subjects with a clinical diagnosis of osteoarthritis of the knee based on clinical ACR criteria and functional capacity class of I – III. Symptoms or radiographic criteria present for at least 3 months
- History of pain in the index joint > 6 months, treated with appropriate analgesics on at least 60 out of the last 90 days. Subjects who have previously used opioids must have experienced a positive therapeutic benefit from these opioids
- Increase in pain intensity in the index joint of at least one point reaching at least 5 points after wash-out period, using NRS
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Evidence or history of psychiatric illness, neurotic personality, severe senile dementia, Alzheimer’s disease, history of seizures or suicide risk, history of head trauma requiring evaluation by hospital based staff. Subjects with well-controlled depression may participate if they have unipolar disorder without manic episodes in personal or family history
- 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
- Creatinine higher than 1.5x upper limit of normal range
- ALT and/or AST higher than 3x upper limit of normal range
- At enrolment ECG with findings which could impact 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
- Acute signs of referred pain, pain of meniscal or ligamental origin and the following pathogenic causes: congenital, direct traumatic, crystal-induced, metabolic, infectious and autoimmune. Clinical diagnosis of fibromyalgia according to ACR-definition
- Previous history of replacement-surgery at the index joint or the subject is expected to require surgical intervention on the index joint
- Intraarticular administration (index joint) of depot-steroids within three months or viscous supplements within six months prior to enrolment
- Start of physiotherapy and/or use of orthopedic devices = 4 weeks prior to enrolment
- Definite or suspected allergy or hypersensitivity to drugs having a similar mechanism of action as investigational medicinal product. Known contraindications/ hypersensitivity to opiods, oxycodone, or paracetamol/ acetaminophen
- Use of fentanyl transdermal system, buprenorphin sublingual or transdermal system, = 7 days prior to enrolment
- Chronic (= 2 weeks) oral intake of corticosteroids less than two weeks prior to enrolment
- Use of antiparkinsonian drugs, MAO-inhibitors, SSRIs, SNRIs, neuroleptics or other drugs that may lower the seizure threshold, = 4 weeks prior to enrolment
- Intake of adjuvant analgesics (e.g. antidepressants, anticonvulsants, muscle relaxants) and of disease modifying drugs (e.g. glucosamines) if not on a stable dose since at least 28 days prior to enrolment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the oral multiple-dose analgesic efficacy and safety of different dosages of GRT0151Y to placebo in subjects with chronic knee-joint osteoarthris;Secondary Objective: To evaluate the oral multiple-dose analgesic efficacy and safety of different dosages of GRT0151Y in comparison to Oxycodone CR in subjects with chronic knee-joint OA.<br>To assess the dose-response of different doses of GRT0151Y in multiple dose administration in chronic pain subjects.<br>To evaluate population pharmacokinetics and pharmacodynamics.;Primary end point(s): Average pain intensity over the preceding 24 hours evaluated at the final visit on an 11-point numeric rating scale (NRS)