Chronic knee and/or hip pain due to Osteoarthritis. MedDRA version: 20.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10020108 Term: Hips osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Product Code: MBZ001
Pharmaceutical Form: Tablet
INN or Proposed INN: tramadol
CAS Number: 36282-47-0
Other descriptive name: TRAMADOL HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Medical Unviersity of Warsaw
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only subjects to whom all of the following conditions apply will be included: 1. Males (not less than 35% of all subjects) and femalesaged 18-75 years. 2. For females, to have a negative pregnancy test at the Baseline (Visit 1) prior to administration of study medication. 3. Females ofnon-childbearing potential or if of childbearing potential, must use a medically acceptable form of contraception for the duration of the study.Females of non-childbearing potential are defined as those who are either surgically sterilised or at least one year post-menopausal. 4. Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate. 5. Adults with a clinical diagnosis of osteoarthritis of the hip and /or knee, based on American College of Rheumatology and radiographic criteria. The presence of typical knee or hip joint symptoms (pain, stiffness, disability) and signs (bony crepitus), and radiographic evidence of osteoarthritis (functional class I-III). 6. Subjects who have a baseline numeric rating scale pain intensity score (NRS-11) =4 (at Day 1) before randomisation to study treatments. 7. Subjects with hip or/and knee osteoarthritis who were judged by investigator as having suboptimal response to non-opioid treatment. 8. Willingness to withhold any medicines that may interfere with tramadol metabolism for 2 weeks prior to the start of the study and continue to withhold them during treatment periods. 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 174
Exclusion criteria
Exclusion criteria: Subjects to whom any of the following conditions apply must be excluded: 1. Inflammatory arthritis, gout, pseudogout, or Paget’s disease of bone that might interfere with the assessment of response. 2. Diagnosis of chronic pain syndrome (lasting longer than 3 months). 3. Clinical diagnosis of fibromyalgia or another major joint or connective tissue disease. 4. Inability to discontinue acetaminophen, COX-2 inhibitors, NSAIDs (other than aspirin 35.0 kg/m2. 18. Pregnancy and breast-feeding female. 19. Infirmity, disability or geographic location that would limit compliance for scheduled visits - subject at risk of non-compliance. 20. Any clinically significant abnormality or other serious or unstable medical or psychological condition identified in the subjects’ medical history, on physical examination or laboratory tests that, in the judgement of the investigator, would compromise the subjects’ safety or successful participation in this Study. 21. Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate efficacy, safety and tolerability of the new formulation composed of tramadol 50 mg and micronized magnesium lactate 75 mg of Mg2+ ionsin the application ofdaily dose 150 mg /225 mgfor the management of chronic pain in subjects with osteoarthritis ofthe hip or/and knee. Non-inferiority study is planned to show that the effect of a new treatment is not worse than that of an active control.;Secondary Objective: The secondary objective of the study is to assess subject acceptance during disease treatment as well as to collect data on subject’s quality of life and the impact on the economy (Cost-Effectiveness Analysis - CEA) and Cost Utility Analysis - CUA).;Primary end point(s): The primary study endpoint is the change between baseline (V1) to End of treatment (V4 or the day of discontinuation) of pain intensity measured on 11-point pain intensity numerical rating scale (PI-NRS) that is achieved on the day of therapy discontinuation or at the end of the trial.;Timepoint(s) of evaluation of this end point: On the day of therapy discontinuation or at the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary study endpoints are: The daily arthritis pain intensity (assessed using a daily subject diary, measured on 11-point pain intensity numerical rating scale) assessment. Proportion of subjects with reduced pain (=1 point) at the each control visit. Proportion of subjects with eliminated pain (0 point) at the each control visit. Proportion of compliant subjects, i.e. those having a compliance more than 80% at the regular therapy end visit. Proportion of subjects recorded rescue medication (Diclofenac ER 100 mg) taken daily. Change from baseline in the WOMAC® Osteoarthritis Index covering the evaluation of the pain, stiffness and physical function assessmentat the Visit 1, Visit 2 and Visit 4. Change from baseline inthe WOMAC® Composite Index (the sum of three subscales scores)at the Visit 1, Visit 2 and Visit 4. Change from baseline in EQ-5D-5L at the Visit 1, Visit 2 and Visit 4. Average cost for health services per subject.;Timepoint(s) of evaluation of this end point: On the day of therapy discontinuation or at the end of the trial. | — |
Countries
Poland
Contacts
Public ContactDepartment of Pharmacodynamics
Medical Unviersity of Warsaw
Outcome results
None listed