Clinical trial NCT02183025: Efficacy and Safety Study of Meloxicam Versus Mefenamic Acid in Patients With Dysmenorrhea
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysmenorrhea
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 337
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

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