TRATAMIENTO INTRAARTICULAR CON MEN 16132 EN PACIENTES AFECTOS DE OSTEOARTRITIS PRIMARIA DE RODILLA EN FASE SINTOMÁTICA: ESTUDIO ALEATORIZADO MULTICÉNTRICO DE BÚSQUEDA DE DOSIS, DOBLE CIEGO Y CONTROLADO CON PLACEBO EN 5 GRUPOS PARALELOSIntra-articular treatment with MEN16132 in patients with symptomatic primary osteoarthritis of the knee: A randomised, multi-centre, double blind, placebo controlled, five parallel group, dose finding study - ALBATROSS - A Locally injected Bradikinin Antagonist for TReatment of OSteoarthitiS

Phase 1

• Conditions: Pacientes afectos de osteoartritis primaria de rodilla en fase sintomáticaPATIENTS WITH SYMPTOMATIC PRIMARY OSTEOARTHRITIS OF THE KNEE; MedDRA version: 12.0Level: LLTClassification code 10031165Term: Osteoarthritis knee

• Registration Number: EUCTR2009-014918-99-ES
• Lead Sponsor: Menarini Ricerche, S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-24
• Study Completion: 2011-05-31
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 423

Inclusion Criteria

1. Written informed consent. 2. Male or female patients > or = 40 years old. 3. Women of childbearing potential are eligible to participate in the study if their pregnancy test (serum ß-hCG) is negative at screening, they are not nursing, and they use an effective method of contraception until all follow-up procedures are complete. Methods of contraception considered effective include oral, injectable or implanted hormonal contraceptive agents, hormone containing intra-uterine devices with failure rates <1% per year. 4. Symptomatic primary knee osteoarthritis (ACR criteria1) since > or = 6 months prior to screening, with documented 'minimal to moderate' radiological se-verity (i.e. Kellgren Lawrence Grade 2 or 3) based on X-ray not older than 6 months, and representing an indication for intra-articular drug injection. 5. >50 mm VAS pain score assigned to the index knee at WOMAC VA 3.1-A1 (pain while walking on a flat surface). 6. >125 mm VAS pain score assigned to the index knee at WOMAC VA 3.1 A subscore (total pain). 7. Pain in the index knee on at least 50% of the days in the month preceding the screening. 8. Minimum flexion of 90 degrees in both knees. 9. Ability to perform the 15 m walk test without the support of crutches or other assistive devices. 10. Willingness to discontinue all pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics) prior to randomisation and for the entire course of the study with a minimum wash-out of 1 or 2 weeks for drugs with short (i.e. < 5 hours) or longer half-life, respectively. NOTE: This does not include paracetamol, up to 1000 mg/day, as rescue medication and low dose aspirin for cardioprotection, up to 100 mg/day or other salicilates at equivalent doses. 11. Willingness to refrain from paracetamol use 48 hours prior to any study visit.
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

1. Inability to personally provide written informed consent (e.g. patients with significant psychiatric illness). 2. Inability to understand or collaborate throughout the study. 3. Subjects who participated in another clinical trial within 30 days prior randomisation. 4. Patients with Kellgren & Lawrence Grade I or IV (doubtful or severe) osteoarthritis of the knee. 5. Knee condition representing an indication for surgery (e.g. significant axial deviation of the knee, severe medio-lateral and/or anterior-posterior instability, severe bone / joint deformity, severe osteoarthritis). 6. Inflammatory or crystal arthropathies (e.g. rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, gout). 7. Patients with acute fractures, severe loss of bone density, bone necrosis. 8. Patients with isolated patella-femoral syndrome or chondromalacia. 9. Patients with OA predominant in the lateral compartment or any significant valgus deformity. 10. Patients with any other disease or condition interfering with the free use and evaluation of the index knee for the 3 month duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis). 11. Major injury or surgery to the index knee within the previous 12 months prior to screening. 12. Severe hip osteoarthritis ipsilateral to index knee. 13. Any pain >30 mm VAS that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee). 14. Any pharmacological or non-pharmacological treatment started or changed during 4 weeks prior to randomisation or likely to be changed during the duration of the study, e.g. acupuncture. Stable treatment for stable chronic disease (e.g. hypertension, coronary heart disease, diabetes, osteoporosis, COPD, asthma incl. inhaled steroids, or physical therapy) is permitted as is the use of oral contraception or hormone replacement therapy IF patients are expected to remain on constant doses throughout the course of the study. 15. Use of systemic or topical corticosteroids >10 mg prednisolone equivalent per day during 30 days prior to randomisation. 16. Use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, anal-gesics during 1 or 2 weeks prior to randomisation for drugs with short (i.e. < 5 hours) or longer half-life, respectively. NOTE: This does not include paracetamol, up to 1000 mg/day, as rescue medication until 48 hours prior to each study Visit, and low dose aspirin for cardioprotection, up to 100 mg/day or other salicilates at equivalent doses. 17. Any acute or newly diagnosed disease/condition requiring treatment. 18. Any chronic disease/condition requiring treatment modification. 19. History of hypersensitivity / allergy to drugs including paracetamol. 20. Patients with any clinically significant abnormal diagnostic test result that may represent a health risk, impact the study or affect the patient's ability to complete the study. 21. Patients with liver disease (i.e. ALT and/or AST >2x upper limit of normal [ULN], and/or conjugated bilirubin >2x ULN). 22. Patients with severe renal insufficiency (serum creatinine >2 mg/dL). 23. Any sign of significant inflammation or infection (e.g. reddening or warmth of the knee, fever, increased CRP, leukocytosis). 24. Any skin disorder or infection overlying the index knee. 25. Previous infection of the index knee. 26. Any intra-articular or local peri-articular punction, injection or surgery to the index knee during

Study & Design

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