A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS (ALBATROSS)
Intra-articular Treatment With MEN16132 in Patients With Symptomatic Primary Osteoarthritis of the Knee: A Randomized, Multi-centre, Double Blind, Placebo Controlled, Five Parallel Group, Dose Finding Study
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Bologna、イタリア、40138
- Servizio di Reumatologia, Ospedale Privato Accreditato Nigrisoli
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Firenze、イタリア、50139
- Dipartimento di Biomedicina - SOD Reumatologia - Azienda Ospedaliera Universitaria Careggi
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Pisa、イタリア、56126
- Dipartimento di Medicina Interna Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara Pisa
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Siena、イタリア、53100
- Istituto di Reumatologia, "Policlinico Le Scotte" Università degli Studi di Siena
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Bilbao、スペイン、48013
- Servicio de Reumatologia, Hospital de Basurto
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Madrid、スペイン、28046
- Servicio de Reumatologia, Hospital Universitario La Paz
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Sabadell、スペイン、08208
- Servicio de Reumatologia, Corporacio Sanitaria Parc Tauli, Hospital de Sabadell
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Sevilla、スペイン、41009
- Servicio de Reumatologia, Hospital Universitario Virgen Macarena
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Bad Doberan、ドイツ、18209
- Rheumatologie/Immunologie - Rheumazentrum, Krankenhaus Doberan
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Berlin、ドイツ、10117
- Klinik für Rheumatologie und Klinische Immunologie, Charité - Campus Charité Mitte
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Berlin、ドイツ、12247
- Orthopädische Praxis Dr. Wagenitz
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Bochum、ドイツ、44787
- ClinPharm International, Prüfzentrum Bochum
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Dresden、ドイツ、01067
- ClinPharm International, Prüfzentrum Dresden
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Erlangen、ドイツ、91054
- Medizinische Klinik 3, Universität Erlangen-Nürnberg
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Frankfurt、ドイツ、60596
- ClinPharm Prüfzentrum Frankfurt / aM
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Görlitz、ドイツ、02826
- ClinPharm Prüfzentrum Görlitz
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Hamburg、ドイツ、22143
- Clinical Research Hamburg
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Hamburg、ドイツ、22767
- Orthopädie Zentrum Altona
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Leipzig、ドイツ、04103
- ClinPharm International, Prüfzentrum Leipzig
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Magdeburg、ドイツ、39104
- ClinPharm Prüfzentrum Magdeburg
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Orléans、フランス、45000
- Centre Hospitalier Régional - Hôpital Porte Madeleine
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Paris、フランス、75181
- Hôtel Dieu - GHU Ouest
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Toulouse、フランス、31300
- Department of Rheumatology, Purpan University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Main Inclusion Criteria:
- Male or female patients ≥40 years old.
- Symptomatic primary knee osteoarthritis (ACR criteria) since ≥6 months prior to screening, Kellgren Lawrence Grade 2 or 3, and representing an indication for intra-articular drug injection.
- >50 mm VAS pain score assigned to the index knee at WOMAC VA 3.1-A1 (pain while walking on a flat surface).
- >125 mm VAS pain score assigned to the index knee at WOMAC VA 3.1 A subscore (total pain).
- Pain in the index knee on at least 50% of the days in the month preceding the screening.
Main Exclusion Criteria:
- Patients with Kellgren & Lawrence Grade I or IV (doubtful or severe) osteoarthritis of the knee.
- Knee condition representing an indication for surgery
- Patients with Inflammatory or crystal arthropathies, acute fractures, severe loss of bone density, bone necrosis.
- Patients with isolated patella-femoral syndrome or chondromalacia.
- Patients with OA predominant in the lateral compartment or any significant valgus deformity.
- 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).
- Major injury or surgery to the index knee within the previous 12 months prior to screening.
- Severe hip osteoarthritis ipsilateral to index knee.
- 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).
- 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
- Use of systemic or topical corticosteroids >10 mg prednisolone equivalent per day during 30 days prior to randomisation.
- Use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics) during 1 or 2 weeks prior to randomisation.
- Any intra-articular or local periarticular punction, injection or surgery to the index knee during the 6 months prior to screening.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Double dose MEN16132 0.125 mg
Intra-articular administration of two 0.125 mg doses of MEN16132 at 2-week interval.
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Intra-articular administration of two low doses of MEN16132 at 2-week interval.
他の名前：
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実験的：Double dose MEN16132 0.25 mg
Intra-articular administration of two 0.25 mg doses of MEN16132 at 2-week interval.
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Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval
他の名前：
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実験的：Double dose MEN16132 0.5 mg
Intra-articular administration of two 0.5 mg doses of MEN16132 at 2-week interval.
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Intra-articular injection of two high doses of MEN16132 at 2-week interval
他の名前：
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
他の名前：
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実験的：Single dose MEN16132 0.5 mg
Intra-articular administration of one 0.5 mg dose of MEN16132 followed by one intra-articular injection of placebo at 2-week interval.
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Intra-articular injection of two high doses of MEN16132 at 2-week interval
他の名前：
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
他の名前：
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プラセボコンパレーター：Placebo
Intra-articular administration of two doses of Placebo at 2-week interval.
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Intra-articular injection of 2 doses of Placebo control at 2-week interval
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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WOMAC VA 3.1 A Score (Total Pain)
時間枠：over the 3 weeks after the first administration
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Western Ontario and McMaster Universities osteoarthritis index (WOMAC). The WOMAC VA 3.1 A score (total pain , range 0-500 mm) is the sum of VAS scores (0-100 mm) attributed by the patient to each of the 5 questions referring to osteoarthritic pain experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 A score, the higher is the intensity of pain symptoms (0 = no pain ; 500 = extreme pain). A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom. The change from baseline was assessed along 3 weeks after first drug administrations. |
over the 3 weeks after the first administration
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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WOMAC VA 3.1.B Score (Knee Stiffness)
時間枠：up to 3 months after first dose
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WOMAC VA 3.1.B score(range 0-200) is the sum of VAS scores (0-100 mm)attributed by the patient to each of the 2 questions referring to joint stiffness experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 B score, the higher is joint stiffness (0 = no stiffness ; 200 = extreme stiffness). A decrease of the WOMAC VA 3.1 B score following treatment administration indicates a reduction of joint stiffness. The change at Week 13 from baseline is reported. |
up to 3 months after first dose
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WOMAC VA 3.1. C Score (Function)
時間枠：up to 3 months after first dose
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Knee function evaluated by WOMAC VA 3.1 C score (range 0-1700) is the sum of VAS scores (range 0-100 mm) attributed by the patient to each of 17 questions referring to difficulty in performing daily activities experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 C score, the higher is functional impairment in daily activities (0 = no difficulty ; 1700 = extreme difficulty). A decrease of the WOMAC VA 3.1 C score following treatment administration indicates an improvement in performing daily activities. WOMAC VA 3.1.C scores at baseline and at Week 13 are reported. |
up to 3 months after first dose
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Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria
時間枠：up to 3 months after first dose
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Osteoarthritis Research Society International (OARSI). Response defined as:
a decrease in the WOMAC pain score by 20% or more and by 10 or more points on the visual analogue scale; a decrease in the WOMAC physical-function score by 20% or more and by 10 or more points on the scale; an improvement in the score on the patient's global assessment by 20% or more and by 10 or more points on the scale. |
up to 3 months after first dose
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Patient Global Assessment
時間枠：up to 3 months after first dose
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Patient global assessment evaluated using a VAS scale score attributed by the patient (range 0-100 mm). Efficacy assessed as change at each time-point post-dosing (week 1, 2 ,3, 13) versus baseline (week 0). A decrease of patient global assessment score indicates an improvement of osteoarthritis symptoms. |
up to 3 months after first dose
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WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]
時間枠：over the 3 weeks after the first administration
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Analysis in normal-weight population (BMI <= 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported. A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom. |
over the 3 weeks after the first administration
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WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]
時間枠：over the 3 weeks after the first administration
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Analysis in over-weight population (BMI > 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported. A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom. |
over the 3 weeks after the first administration
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Adverse Event Reports
時間枠：up to 4 months after screening
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Incidence of spontaneously reported adverse events
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up to 4 months after screening
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Clinically Significant Abnormal Laboratory Tests
時間枠：up to 4 months from screening
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Percentage of patients with Abnormal Laboratory Tests judged Clinically Significant by Investigators. The following hematochemical and urinary parameters were analysed: Red Blood Cells Count, Haematocrit, Haemoglobin, Platelets, MCV, MCH, MCHC, White Blood Cells, Sodium, Chloride, Potassium, Total calcium, AST (SGOT), ALT (SGPT), GGT, Alkaline phosphatase, Total Bilirubin, Direct Bilirubin, Creatinine, BUN, CPK, LDH, Glucose, Total proteins, Albumin. |
up to 4 months from screening
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Karel Pavelka, Prof MD、Institute of Rheumatology, Charles University Prague
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- BKOS-02
- 2009-014918-99 (EudraCT番号)
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