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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dysmenorrhea

Intervention: 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 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Boehringer Ingelheim

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

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Evaluation of severity of lumbar and/or abdominal pain on a visual analogue scale (VAS)

Secondary outcome:

Final global assessment of efficacy by patient on a 4-point scale

Final global assessment of efficacy by investigator on a 4-point scale

Final global assessment of tolerability by patient on a 4-point scale

Final global assessment of tolerability by investigator on a 4-point scale

Number of Participants with Adverse Events (AE)

Incidence of significant laboratory events

Number of perforations, ulcerations and/or bleedings (PUB) of the upper gastro-intestinal tract

Number of gastro-intestinal adverse events (GI-AEs)

Duration of hospitalization stay due to GI-AEs

Number of additional visits at physician due to GI-AEs

Duration of hospitalization due to drug related AEs

Number of withdrawals due to AEs

Intensity of AEs on a 3-point scale

Evaluation of labor and/or daily life disability associated with dysmenorrhea on a VAS

Change in severity of symptomatology associated with dysmenorrhea

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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

Locations and Contacts

Additional Information

Starting date: January 1998
Last updated: July 4, 2014

Page last updated: August 23, 2015

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