A Study Comparing the Effectiveness and Safety of Tramadol and micronized magnesium lactate as functional excipient to Tramadol alone for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA).

Phase 1

• Conditions: Chronic knee and/or hip pain due to Osteoarthritis.; MedDRA version: 20.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; MedDRA version: 20.0Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-004718-27-PL
• Lead Sponsor: Medical Unviersity of Warsaw

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-01
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 294

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

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 <325 mg QD for cardiovascular prophylaxis), corticosteroids, or other analgesics for the duration of the clinical study.
5. Use of oral, intramuscular, intravenous, or soft tissue corticosteroids within 1 month prior to the study.
6. History of clinically significant intolerance to tramadol or a known hypersensitivity to opioid analgesics; and increased risk in terms of the precautions, warnings, and contraindications noted in the tramadol prescribing information.
7. History of clinically significant intolerance or a known hypersensitivity to non-steroid anti-inflammatory drugs; and increased risk in terms of the precautions, warnings, and contraindications noted in the diclofenac prescribing information. 8. Uncontrolled concomitant disease or chronic condition(s)need of medical treatment that might interfere with the assessment of pain and other symptoms of osteoarthritis including: Epilepsy in medical history; History of serious insufficiency of the kidney or liver; Parkinson disease; History of extrapyramidal symptoms; History of or current depressive disorders and antidepressive treatment being continued; History of unstable ischaemic disease, cardiac arrhythmia, unstable arterial hypertension.
9. History of, or reason to believe a participant has a history of narcotic or alcohol abuse as well as sedative drugs use including hypnotics, other analgesics like morphine or codeine and any other drugs that have a sedating potential.
10. HIV, Hepatitis B or C in subject history.
11. Treatment with MAO inhibitors within the period shorter than 30 days prior to study enrolment.
12. Antipsychotic or antidepressant or anticonvulsant used drugs or treatment during 2 weeks prior to study enrolment.
13. Miastenia gravis.
14. Tramadol or magnesium treatment being considered as contraindicated by investigator.
15. Use of any dietary supplements containing magnesium14 days prior to study enrolmentor during the study.
16. Ongoing treatment with calcium blockers, gabapentine, pregabaline and anticoagulant.
17. Body mass index (BMI) > 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.

Study & Design

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