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

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

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

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea
• Intervention / Treatment: Drug: Meloxicam 15 mg; Drug: Meloxicam 7.5 mg; Drug: Placebo matching 15 mg meloxicam; Drug: Placebo matching 500 mg mefenamic acid; Drug: Placebo matching 7.5 mg meloxicam; Drug: Mefenamic acid 500 mg

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 1998
• Primary Completion (Actual): April 1, 1999

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Mefenamic Acid; Meloxicam
• Other Study ID Numbers: 107.191