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

NCT02183025 | Completed Phase 2

• 1 other identifier: 107.191
• Study Type: interventional
• Target: 337
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Study Arms (3)

Meloxicam 7.5 mg

EXPERIMENTAL

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

Meloxicam 15 mg

EXPERIMENTAL

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

Mefenamic acid 1500 mg

ACTIVE COMPARATOR

500 mg three times daily

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

Interventions

Meloxicam 7.5 mg DRUG

Meloxicam 7.5 mg

Meloxicam 15 mg DRUG

Meloxicam 15 mg

Mefenamic acid 500 mg DRUG

Mefenamic acid 1500 mg

Placebo matching 7.5 mg meloxicam DRUG

Mefenamic acid 1500 mg; Meloxicam 15 mg

Placebo matching 15 mg meloxicam DRUG

Mefenamic acid 1500 mg; Meloxicam 7.5 mg

Placebo matching 500 mg mefenamic acid DRUG

Meloxicam 15 mg; Meloxicam 7.5 mg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Meloxicam; Mefenamic Acid

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: January 1, 1998
• Primary Completion: April 1, 1999
• Last Updated: August 31, 2018

Record last verified: 2018-08