Conditions: Osteoarthritis, Knee
Keywords: Injections, Intra-Articular
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 423
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.

Detailed description:
MEN16132 is a non-peptide bradykinin B2-receptor antagonist showing analgesic and anti-inflammatory activity in nonclinical osteoarthritis models. This study is being conducted as a dose finding study to determine the safety and efficacy of MEN16132, given as three doses/four treatment regimens in comparison to placebo, as well the time to onset and duration of effect.

Arms:
arm 1: Intra-articular administration of two 0.125 mg doses of MEN16132 at 2-week interval. arm 2: Intra-articular administration of two 0.25 mg doses of MEN16132 at 2-week interval. arm 3: Intra-articular administration of two 0.5 mg doses of MEN16132 at 2-week interval. arm 4: Intra-articular administration of one 0.5 mg dose of MEN16132 followed by one intra-articular injection of placebo at 2-week interval. arm 5: Intra-articular administration of two doses of Placebo at 2-week interval.

Interventions: intervention 1: MEN16132 - 0.125 mg intervention 2: MEN16132 - 0.25 mg intervention 3: MEN16132 - 0.5 mg intervention 4: MEN16132 - 0.5 mg intervention 5: Placebo
Intervention descriptions: intervention 1: Intra-articular administration of two low doses of MEN16132 at 2-week interval. intervention 2: Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval intervention 3: Intra-articular injection of two high doses of MEN16132 at 2-week interval intervention 4: Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval intervention 5: Intra-articular injection of 2 doses of Placebo control at 2-week interval

Protocol document: