Botulinum Toxin Serotype A randomized double-blind, placebo controlled multicentre study for degenerative coxarthrosis.

INTERVENTION: Trade Name: DYSPORT*SC IM 2FL 500U Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: BOTULINUM TOXIN TYPE A CAS Number: 93384‐43‐1 Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 250‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use CONDITION: coxarthrosis ; MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 ‐ Musculoskeletal and connective tissue disorders Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: The primary efficacy variables will be the Harris Hip Score (HHS) at week 4. Primary end point(s): The primary efficacy variables will be the Harris Hip Score (HHS) at week 4. Secondary Objective: Secondary efficacy variables will be considered the following : ; the Harris Hip Score (HHS) at week 2 and 12; the Subjective reporting of pain intensity (by a Visual Analogue Scale VAS) at week 2, 4, 12; the MRC scale (Scale to evaluate the muscular strength) and the SF‐36 Quality of Life questionnaire. at week 2, 4, 12. Timepoint(s) of evaluation of this end point: 4 weeks SECONDARY OUTCOME: Secondary end point(s): Secondary efficacy variables will be considered the following : ; the Harris Hip Score (HHS) at week 2 and 12; the Subjective reporting of pain intensity (by a Visual Analogue Scale VAS) at week 2, 4, 12; the MRC scale (Scale to evaluate the muscular strength) and the SF‐36 Quality of Life questionnaire. at week 2, 4, 12. Timepoint(s) of evaluation of this end point: 2, 4, 12 weeks INCLUSION CRITERIA: All patients must fulfil the following criteria: Subjects with primary or secondary symptomatic painful coxarthrosis, defined by radiographic signs (Rx or MRI or TC Scan) (see Table 1) and quantitative measurement of joint space ‐ Age between 18 ‐ 80 years ‐ Written Voluntary Consent of the subject ‐ Impossibility of surgical treatment or elective surgery after six month to orthopaedic visit ‐ HHS > 20 (because in the previous study baseline HHS was 40 +/‐ 21) VAS > 4 (minimal value defined as “significant pain”) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54