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

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ClinicalTrials.gov Identifier: NCT02183025
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Dysmenorrhea Drug: Meloxicam 7.5 mg Drug: Meloxicam 15 mg Drug: Mefenamic acid 500 mg Drug: Placebo matching 7.5 mg meloxicam Drug: Placebo matching 15 mg meloxicam Drug: Placebo matching 500 mg mefenamic acid Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 337 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 1998
Actual Primary Completion Date : April 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

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



Primary Outcome Measures :
  1. Evaluation of severity of lumbar and/or abdominal pain on a visual analogue scale (VAS) [ Time Frame: Baseline and day 3-5 of each treatment cycle ]

Secondary Outcome Measures :
  1. Final global assessment of efficacy by patient on a 4-point scale [ Time Frame: day 3-5 of the second treatment cycle ]
  2. Final global assessment of efficacy by investigator on a 4-point scale [ Time Frame: day 3-5 of the second treatment cycle ]
  3. Final global assessment of tolerability by patient on a 4-point scale [ Time Frame: day 3-5 of the second treatment cycle ]
  4. Final global assessment of tolerability by investigator on a 4-point scale [ Time Frame: day 3-5 of the second treatment cycle ]
  5. Number of Participants with Adverse Events (AE) [ Time Frame: Up to 4 weeks after last treatment cycle ]
  6. Incidence of significant laboratory events [ Time Frame: Up to 4 weeks after last treatment cycle ]
  7. Number of perforations, ulcerations and/or bleedings (PUB) of the upper gastro-intestinal tract [ Time Frame: Up to 4 weeks after last treatment cycle ]
  8. Number of gastro-intestinal adverse events (GI-AEs) [ Time Frame: Up to 4 weeks after last treatment cycle ]
  9. Duration of hospitalization stay due to GI-AEs [ Time Frame: Up to 4 weeks after last treatment cycle ]
  10. Number of additional visits at physician due to GI-AEs [ Time Frame: Up to 4 weeks after last treatment cycle ]
  11. Duration of hospitalization due to drug related AEs [ Time Frame: Up to 4 weeks after last treatment cycle ]
  12. Number of withdrawals due to AEs [ Time Frame: Up to 4 weeks after last treatment cycle ]
  13. Intensity of AEs on a 3-point scale [ Time Frame: Up to 4 weeks after last treatment cycle ]
  14. Evaluation of labor and/or daily life disability associated with dysmenorrhea on a VAS [ Time Frame: Baseline and day 3-5 of each treatment cycle ]
  15. Change in severity of symptomatology associated with dysmenorrhea [ Time Frame: Baseline and day 3-5 of each treatment cycle ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183025     History of Changes
Other Study ID Numbers: 107.191
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Meloxicam
Mefenamic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action