A PHASE II DOUBLE BLIND MODIFIED CROSS OVER DESIGN STUDY EVALUATING THE EFFICACY AND SAFETY OF TRIMETAZIDINE (GENERICS UK LIMITED) AND PLACEBO IN THE TREATMENT OF FIBROMYALGIA

INTERVENTION: Trade Name: TRIMETAZIDINE MERCK 20 mg Pharmaceutical Form: Coated tablet INN or Proposed INN: Trimetazidine dihydrochloride CAS Number: 13171‐25‐0 Current Sponsor code: Trimetazidine Merck Other descriptive name: Trimetazidine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use CONDITION: Fibromyalgia ; MedDRA version: 9.1 Level: LLT Classification code 10048439 Term: Fibromyalgia PRIMARY OUTCOME: Main Objective: The primary objective of this study is to demonstrate the efficacy of trimetazidine in subjects with fibromyalgia by testing the hypothesis that the test product trimetazidine is superior to placebo in reducing pain, as determined by the change from baseline of the pain visual analogue score after 10 days treatment. Primary end point(s): Change from baseline on the pain visual analogue score of the mean pain measured over the last 3 days of the treatment period. Secondary Objective: The secondary objective of this study is to further explore efficacy and safety of trimetazidine as compared to placebo in subjects with fibromyalgia. INCLUSION CRITERIA: Subjects fulfilling the following criteria are eligible for participation in the study: (1) Male or female (2) Age equal or more than18 years (3) Body weight between 60 and 130 kg for males and 50 and 110 kg for females. In addition the BMI range limit of 18 – 32 kg/m2 (both inclusive) is applicable . (4) Diagnosed by an expert as having primary fibromyalgia. (5) Newly diagnosed subjects or uncontrolled subjects currently experiencing pain (score > 5 < 8 on the VAS) (6) No significant concurrent illness apart from fibromyalgia (7) Available for the entire study period and are willing to adhere to the protocol requirements. (8) Have signed consent form after the nature of the study has been fully explained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects fo