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Completed

NCT Number: NCT01091116

A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Régional - Hôpital Porte Madeleine, Orléans, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MEN16132 - 0.125 mg

Drug

Intra-articular administration of two low doses of MEN16132 at 2-week interval.

Other names: fasitibant 0.125 mg

MEN16132 - 0.25 mg

Drug

Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval

Other names: fasitibant 0.25 mg

MEN16132 - 0.5 mg

Drug

Intra-articular injection of two high doses of MEN16132 at 2-week interval

Other names: fasitibant 0.5 mg

Placebo

Drug

Intra-articular injection of 2 doses of Placebo control at 2-week interval

Primary outcomes

  1. WOMAC VA 3.1 A Score (Total Pain)

    Time frame: over the 3 weeks after the first administration

    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.

Secondary outcomes

  1. WOMAC VA 3.1.B Score (Knee Stiffness)

    Time frame: up to 3 months after first dose

    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.

  2. WOMAC VA 3.1. C Score (Function)

    Time frame: up to 3 months after first dose

    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.

  3. Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria

    Time frame: up to 3 months after first dose

    Osteoarthritis Research Society International (OARSI).

    Response defined as:

    • a decrease in WOMAC pain or physical-function score by 50% or more and by 20 or more points on the visual analogue scale
    • OR if two of the following three findings are recorded:

    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.

  4. Patient Global Assessment

    Time frame: up to 3 months after first dose

    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.

  5. WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]

    Time frame: over the 3 weeks after the first administration

    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.

  6. WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]

    Time frame: over the 3 weeks after the first administration

    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.

  7. Adverse Event Reports

    Time frame: up to 4 months after screening

    Incidence of spontaneously reported adverse events

  8. Clinically Significant Abnormal Laboratory Tests

    Time frame: up to 4 months from screening

    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.

Sponsors and collaborators

Lead sponsor

Menarini Group

Industry

Registry information

Official study title

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

Acronym: ALBATROSS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 23, 2010
Registry last updated
Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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