RALFINAMIDEEFFICACY OF RALFINAMIDE IN PATIENTS WITH THIRD MOLAR             POST-EXTRACTION DENTAL PAIN.                  ...
INTRODUCTION;The objectives of this study are to evaluate the safety, tolerability and preliminaryevidence of analgesic ef...
Study Randomised,Type Placebo-controlled,        Double-blind Study            Drug: RalfinamideStudy Phase 2PhaseConditio...
STUDYDURATIONSTUDYPOPULATION   A minimum of 180 patients (90 patients per group)             Randomised (1:1)             ...
ELIGIBILITYCRITERIA Inclusion Criteria:           Patient is ≥18 years of age. If female, the patient must be post-      ...
Screening      a) All laboratory results must be available before the decision is made(Visit 1: Day      to enrol the pati...
Baseline        higher dose of study medication.(Visit 3: Day 0) Dose Level 1: 4 tablets; if on Dose Level 0: 2 tablets.  ...
EFFICACY ANALYSISPRIMARY        The Cox regression model will be adopted to evaluateEFFICACY      treatment effectANALYSIS...
FINANCIAL       NEWRON Pharmaceuticals.AGREEMENTREGULATORY     This study will be conducted in accordance with the Declara...
ADMINISTRATIVE INFORMATIONPROTOCOLNUMBER      NW-1029/002/II/2007SPONSOR:             Newron Pharmaceuticals S.p.A.       ...
Ralfinamide
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Ralfinamide

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Ralfinamide

  1. 1. RALFINAMIDEEFFICACY OF RALFINAMIDE IN PATIENTS WITH THIRD MOLAR POST-EXTRACTION DENTAL PAIN. by RAHUL challarahul77@gmail.com
  2. 2. INTRODUCTION;The objectives of this study are to evaluate the safety, tolerability and preliminaryevidence of analgesic efficacy of orally administered ralfinamide at a target dose of480 mg/day, compared to placebo, in patients with third molar, post-extraction,dental pain.Gender BothAges 18 Years and olderAccepts NoHealthyVolunteers
  3. 3. Study Randomised,Type Placebo-controlled, Double-blind Study Drug: RalfinamideStudy Phase 2PhaseCondition Post-Extraction Dental Pain
  4. 4. STUDYDURATIONSTUDYPOPULATION A minimum of 180 patients (90 patients per group) Randomised (1:1) 20 centres, in 2 countries (India and Romania)
  5. 5. ELIGIBILITYCRITERIA Inclusion Criteria: Patient is ≥18 years of age. If female, the patient must be post- menopausal for at least 12 months, surgically sterilized or have undergone hysterectomy. Patients must be scheduled to undergo extraction of one or more third molar(s), of which at least one must be either partially or completely impacted in the mandibular bone. Exclusion Criteria: If female, the patient is of childbearing potential, pregnant or lactating. Women less than 50 years of age will be required to have a pregnancy test at screening. Patient has a chronic pain condition requiring continuous treatment with analgesics. History of alcohol or drug abuse Severe thyroid dysfunction, rheumatoid arthritis or vasculitis. Second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, significant ECG abnormalities
  6. 6. Screening a) All laboratory results must be available before the decision is made(Visit 1: Day to enrol the patient and start treatment at Visit 2.-8) b) vital signs – height, body weight, temperature, pulse, systolic and diastolic BP, respiratory rate. c) medical history d) physical examination e) neurological examination Run-in period a) Eligible patients will enter a 3-day run-in period during which all(Days –8 to –6) screening evaluations must be completed b) Patients with clinically significant abnormal laboratory values that do not normalize prior to Visit 2 will not be randomised to the treatment phase Pre-Surgery (Dose Level 1):Treatment Ralfinamide 320 mg/day (160 mg b.i.d.); orPeriod (Visit 2: • Placebo.Days –5 to –1)
  7. 7. Baseline higher dose of study medication.(Visit 3: Day 0) Dose Level 1: 4 tablets; if on Dose Level 0: 2 tablets. Safety evaluations performed pre-surgery (Day 0); efficacy evaluated in clinic for 6 hr post-surgery (Day 1); patient dispensed medication and given pain diary to complete at home. Post-Surgery 6-hr evaluation period during.Treatmentperiod Any adverse events that occur during this period must be recorded.(Visits 4, 5 and patients will be required to complete the PGART6: Days 1, 2and 3) On Day 3, the Investigator will perform the final evaluations when the patient returns to the clinic.
  8. 8. EFFICACY ANALYSISPRIMARY The Cox regression model will be adopted to evaluateEFFICACY treatment effectANALYSIS Results will be reported as hazard ratios (HRs) with associated two- tailed 95% confidence intervals.SECONDARY Wilcoxon Rank Sum test & whilst treatmentEFFICACYANALYSIS Differences will be reported as Hodges-Lehmann estimates with associated non parametric 95%
  9. 9. FINANCIAL NEWRON Pharmaceuticals.AGREEMENTREGULATORY This study will be conducted in accordance with the Declaration ofREQUIREMENTS Helsinki and the ICH E6 Guideline (Good Clinical Practice).INSURANCE NEWRON will provide insurance coverage for damages emergingPOLICY from the trial and involving the subjects treated
  10. 10. ADMINISTRATIVE INFORMATIONPROTOCOLNUMBER NW-1029/002/II/2007SPONSOR: Newron Pharmaceuticals S.p.A. via L. Ariosto 21, 20091 Bresso (MI), ItalyPROTOCOL YESAPPROVAL 14 MAY 2007

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