Efficacy and Safety Study of Meloxicam Versus Mefenamic Acid in Patients With Dysmenorrhea

Study Overview
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Brief Summary
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To access the efficacy and safety of Meloxicam 7.5 mg and 15 mg once daily compared with Mefenamic acid 500 mg t.i.d. over a treatment period of 3-5 days, during an observation period of 3 menstrual cycles, for the symptomatic relief of primary dysmenorrhea

Official Title
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Double Blind Study to Evaluate Efficacy and Safety of Meloxicam 7.5 mg and 15 mg Versus Mefenamic Acid 1500 mg in the Treatment of Dysmenorrhea

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Drug: Meloxicam 7.5 mg
* Drug: Meloxicam 15 mg
* Drug: Mefenamic acid 500 mg
* Drug: Placebo matching 7.5 mg meloxicam
* Drug: Placebo matching 15 mg meloxicam
* Drug: Placebo matching 500 mg mefenamic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients between 18 to 40 years Patients experiencing primary (functional) dysmenorrhea during the last 3 consecutive menstrual periods. Diagnosis will be based on symptoms and clinical signs: abdominopelvic pain, may radiate to the back and along the thighs; systemic symptoms including nausea, vomit, diarrhoea, headache, fatigue, nervousness, dizziness; the symptomatology should be usually some hours to one day before commencement of visible vaginal bleeding Evaluation of lumbar and/or abdominopelvic pain due to dysmenorrhea > 35 mm through a 100 mm visual analogue scale (VAS) Outpatients Patients granting their written informed consent Therapy with a NSAID (nonsteroidal antiinflammatory drug) is required or recommended Exclusion Criteria: Known or suspected hypersensitivity to trial drugs or their excipients, analgesics, antipyretics or NASIDs Analgesic concomitant treatment (between each cycle paracetamol administration will be allowed) To initiate hormonal contraception or intrauterine devices after inclusion to this trial or during the last 3 months Abdominal surgery or pelvic procedure scheduled during the study Patients with organic dysmenorrhea (endometriosis, salpingitis, adnexitis, uterine retroversion, tubal cysts, ovarian cysts, pathological vaginal secretion, painful pelvic exploration, etc.) Patients with neoplastic disorders History of recent abdominal or pelvic trauma requiring surgery Peptic ulcer within the past 6 months Pregnancy or breast feeding Asthma, nasal polyps, angioneurotic edema or rash following aspirin or NSAIDs administration Concomitant treatment with anti-coagulants, including heparin and aspirin, lithium or methotrexate Concomitant administration of other NSAIDs (including aspirin > 150 mg daily) or analgesics Confinement to bed rest Administration of any NSAID during two days (three for oxicams) before the first administration of the trial drug Present treatment or treatment within the last two months with corticosteroids Impaired renal function (serum urea > 125 % of the upper limit of normal range; serum creatinine > 150 % of the upper limit of normal range) Sever liver injury (alanine amino transferase ALAT > 2 x the upper normal range limit or aspartate amino transferase ASAT > 2 x the upper normal range limit) Hematological disorder (platelet count < 100,000/mm**3, leucocyte count < 3,000/mm**3) Participation in another clinical trial during this study or the previous month Previous participation in this trial Patient unable to comply with protocol Bleeding disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meloxicam 7.5 mg<br> | Drug: Meloxicam 7.5 mg<br> <br> Drug: Placebo matching 15 mg meloxicam<br> <br> Drug: Placebo matching 500 mg mefenamic acid<br> <br> |
| Experimental: Meloxicam 15 mg<br> | Drug: Meloxicam 15 mg<br> <br> Drug: Placebo matching 7.5 mg meloxicam<br> <br> Drug: Placebo matching 500 mg mefenamic acid<br> <br> |
| Active Comparator: Mefenamic acid 1500 mg<br>500 mg three times daily | Drug: Mefenamic acid 500 mg<br> <br> Drug: Placebo matching 7.5 mg meloxicam<br> <br> Drug: Placebo matching 15 mg meloxicam<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of severity of lumbar and/or abdominal pain on a visual analogue scale (VAS) |  | Baseline and day 3-5 of each treatment cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final global assessment of efficacy by patient on a 4-point scale |  | day 3-5 of the second treatment cycle | 
| Final global assessment of efficacy by investigator on a 4-point scale |  | day 3-5 of the second treatment cycle | 
| Final global assessment of tolerability by patient on a 4-point scale |  | day 3-5 of the second treatment cycle | 
| Final global assessment of tolerability by investigator on a 4-point scale |  | day 3-5 of the second treatment cycle | 
| Number of Participants with Adverse Events (AE) |  | Up to 4 weeks after last treatment cycle | 
| Incidence of significant laboratory events |  | Up to 4 weeks after last treatment cycle | 
| Number of perforations, ulcerations and/or bleedings (PUB) of the upper gastro-intestinal tract |  | Up to 4 weeks after last treatment cycle | 
| Number of gastro-intestinal adverse events (GI-AEs) |  | Up to 4 weeks after last treatment cycle | 
| Duration of hospitalization stay due to GI-AEs |  | Up to 4 weeks after last treatment cycle | 
| Number of additional visits at physician due to GI-AEs |  | Up to 4 weeks after last treatment cycle | 
| Duration of hospitalization due to drug related AEs |  | Up to 4 weeks after last treatment cycle | 
| Number of withdrawals due to AEs |  | Up to 4 weeks after last treatment cycle | 
| Intensity of AEs on a 3-point scale |  | Up to 4 weeks after last treatment cycle | 
| Evaluation of labor and/or daily life disability associated with dysmenorrhea on a VAS |  | Baseline and day 3-5 of each treatment cycle | 
| Change in severity of symptomatology associated with dysmenorrhea |  | Baseline and day 3-5 of each treatment cycle |