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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Dysmenorrhea

Treatments: Drug: Placebo matching 15 mg meloxicam; Drug: Meloxicam 7.5 mg; Drug: Placebo matching 500 mg mefenamic acid; Drug: Mefenamic acid 500 mg; Drug: Placebo matching 7.5 mg meloxicam; Drug: Meloxicam 15 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183025

107.191

Details and patient eligibility

About

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

Enrollment: 337 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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337 participants in 3 patient groups

Meloxicam 7.5 mg

Experimental group

Treatment:

Drug: Meloxicam 7.5 mg

Drug: Placebo matching 500 mg mefenamic acid

Drug: Placebo matching 15 mg meloxicam

Meloxicam 15 mg

Experimental group

Treatment:

Drug: Placebo matching 500 mg mefenamic acid

Drug: Placebo matching 7.5 mg meloxicam

Drug: Meloxicam 15 mg

Mefenamic acid 1500 mg

Active Comparator group

Description:

500 mg three times daily

Treatment:

Drug: Mefenamic acid 500 mg

Drug: Placebo matching 7.5 mg meloxicam

Drug: Placebo matching 15 mg meloxicam