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

NCT ID: NCT02183025

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 337 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-01-31

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

Conditions

Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Meloxicam 7.5 mg

Group Type: EXPERIMENTAL

Meloxicam 7.5 mg

Intervention Type: DRUG

Placebo matching 15 mg meloxicam

Intervention Type: DRUG

Placebo matching 500 mg mefenamic acid

Intervention Type: DRUG

Meloxicam 15 mg

Group Type: EXPERIMENTAL

Meloxicam 15 mg

Intervention Type: DRUG

Placebo matching 7.5 mg meloxicam

Intervention Type: DRUG

Placebo matching 500 mg mefenamic acid

Intervention Type: DRUG

Mefenamic acid 1500 mg

500 mg three times daily

Group Type: ACTIVE_COMPARATOR

Mefenamic acid 500 mg

Intervention Type: DRUG

Placebo matching 7.5 mg meloxicam

Intervention Type: DRUG

Placebo matching 15 mg meloxicam

Intervention Type: DRUG

Interventions

Meloxicam 7.5 mg

Intervention Type: DRUG

Meloxicam 15 mg

Intervention Type: DRUG

Mefenamic acid 500 mg

Intervention Type: DRUG

Placebo matching 7.5 mg meloxicam

Intervention Type: DRUG

Placebo matching 15 mg meloxicam

Intervention Type: DRUG

Placebo matching 500 mg mefenamic acid

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

107.191

Identifier Type: -

Identifier Source: org_study_id