Back to resultsEfficacy and Safety Study of Meloxicam Versus Mefenamic Acid in Patients With Dysmenorrhea
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Meloxicam 7.5 mg
Meloxicam 15 mg
Mefenamic acid 1500 mg
Arm Description
500 mg three times daily
Outcomes
Primary Outcome Measures
Evaluation of severity of lumbar and/or abdominal pain on a visual analogue scale (VAS)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02183025
Brief Title
Efficacy and Safety Study of Meloxicam Versus Mefenamic Acid in Patients With Dysmenorrhea
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 Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
April 1999 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
337 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meloxicam 7.5 mg
Arm Type
Experimental
Arm Title
Meloxicam 15 mg
Arm Type
Experimental
Arm Title
Mefenamic acid 1500 mg
Arm Type
Active Comparator
Arm Description
500 mg three times daily
Intervention Type
Drug
Intervention Name(s)
Meloxicam 7.5 mg
Intervention Type
Drug
Intervention Name(s)
Meloxicam 15 mg
Intervention Type
Drug
Intervention Name(s)
Mefenamic acid 500 mg
Intervention Type
Drug
Intervention Name(s)
Placebo matching 7.5 mg meloxicam
Intervention Type
Drug
Intervention Name(s)
Placebo matching 15 mg meloxicam
Intervention Type
Drug
Intervention Name(s)
Placebo matching 500 mg mefenamic acid
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Final global assessment of efficacy by patient on a 4-point scale
Time Frame
day 3-5 of the second treatment cycle
Title
Final global assessment of efficacy by investigator on a 4-point scale
Time Frame
day 3-5 of the second treatment cycle
Title
Final global assessment of tolerability by patient on a 4-point scale
Time Frame
day 3-5 of the second treatment cycle
Title
Final global assessment of tolerability by investigator on a 4-point scale
Time Frame
day 3-5 of the second treatment cycle
Title
Number of Participants with Adverse Events (AE)
Time Frame
Up to 4 weeks after last treatment cycle
Title
Incidence of significant laboratory events
Time Frame
Up to 4 weeks after last treatment cycle
Title
Number of perforations, ulcerations and/or bleedings (PUB) of the upper gastro-intestinal tract
Time Frame
Up to 4 weeks after last treatment cycle
Title
Number of gastro-intestinal adverse events (GI-AEs)
Time Frame
Up to 4 weeks after last treatment cycle
Title
Duration of hospitalization stay due to GI-AEs
Time Frame
Up to 4 weeks after last treatment cycle
Title
Number of additional visits at physician due to GI-AEs
Time Frame
Up to 4 weeks after last treatment cycle
Title
Duration of hospitalization due to drug related AEs
Time Frame
Up to 4 weeks after last treatment cycle
Title
Number of withdrawals due to AEs
Time Frame
Up to 4 weeks after last treatment cycle
Title
Intensity of AEs on a 3-point scale
Time Frame
Up to 4 weeks after last treatment cycle
Title
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
Title
Change in severity of symptomatology associated with dysmenorrhea
Time Frame
Baseline and day 3-5 of each treatment cycle
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.191_U01-3305.pdf
Description
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Efficacy and Safety Study of Meloxicam Versus Mefenamic Acid in Patients With Dysmenorrhea
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