Phase 2
Completed N=423
A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT01091116 ↗
Enrolled (actual)
423
Serious AEs
2.6%
Results posted
Feb 2013
Primary outcomePrimary: WOMAC VA 3.1 A Score (Total Pain) — -60; -58; -52; -67 mm — p=0.5263
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WOMAC VA 3.1 A Score (Total Pain) |
-60; -58; -52; -67; -63; -69 | 0.5263 |
| SECONDARY WOMAC VA 3.1.B Score (Knee Stiffness) |
105.7; 101.8; 109.4; 107.3; 108.7; 61.5 | — |
| SECONDARY WOMAC VA 3.1. C Score (Function) |
928.7; 915.5; 906.7; 938.7; 936.5; 537.5 | — |
| SECONDARY Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria |
44.6; 35.6; 36.6; 41.5; 44.4; 46.3 | — |
| SECONDARY Patient Global Assessment |
-4.2; -3.3; 0.9; -6.3; -7.8; -4.7 | — |
| SECONDARY WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25] |
-11.4; -72.4; -109.0; -109.0; 2.7; 9.2 | — |
| SECONDARY WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25] |
-76.5; -62.9; -56.4; -67.4; -58.0; -88.2 | — |
| SECONDARY Adverse Event Reports |
31; 38; 36; 28; 33; 1 | — |
| SECONDARY Clinically Significant Abnormal Laboratory Tests |
0; 0; 1; 0; 1; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01091116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.