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

Dysmenorrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183025
• Other study ID #: 107.191
• Status: Completed
• Phase: Phase 2
• Start date: January 1998

Study information

• Verified date: August 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. primary completion date: April 1999
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• Meloxicam 7.5 mg

• Meloxicam 15 mg

• Mefenamic acid 500 mg

• Placebo matching 7.5 mg meloxicam

• Placebo matching 15 mg meloxicam

• Placebo matching 500 mg mefenamic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Final global assessment of efficacy by patient on a 4-point scale		day 3-5 of the second treatment cycle
Secondary	Final global assessment of efficacy by investigator on a 4-point scale		day 3-5 of the second treatment cycle
Secondary	Final global assessment of tolerability by patient on a 4-point scale		day 3-5 of the second treatment cycle
Secondary	Final global assessment of tolerability by investigator on a 4-point scale		day 3-5 of the second treatment cycle
Secondary	Number of Participants with Adverse Events (AE)		Up to 4 weeks after last treatment cycle
Secondary	Incidence of significant laboratory events		Up to 4 weeks after last treatment cycle
Secondary	Number of perforations, ulcerations and/or bleedings (PUB) of the upper gastro-intestinal tract		Up to 4 weeks after last treatment cycle
Secondary	Number of gastro-intestinal adverse events (GI-AEs)		Up to 4 weeks after last treatment cycle
Secondary	Duration of hospitalization stay due to GI-AEs		Up to 4 weeks after last treatment cycle
Secondary	Number of additional visits at physician due to GI-AEs		Up to 4 weeks after last treatment cycle
Secondary	Duration of hospitalization due to drug related AEs		Up to 4 weeks after last treatment cycle
Secondary	Number of withdrawals due to AEs		Up to 4 weeks after last treatment cycle
Secondary	Intensity of AEs on a 3-point scale		Up to 4 weeks after last treatment cycle
Secondary	Evaluation of labor and/or daily life disability associated with dysmenorrhea on a VAS		Baseline and day 3-5 of each treatment cycle
Secondary	Change in severity of symptomatology associated with dysmenorrhea		Baseline and day 3-5 of each treatment cycle