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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam 7.5 mg | Experimental |
| |
| Meloxicam 15 mg | Experimental |
| |
| Mefenamic acid 1500 mg | Active Comparator | 500 mg three times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam 7.5 mg | Drug |
| ||
| Meloxicam 15 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of severity of lumbar and/or abdominal pain on a visual analogue scale (VAS) | Baseline and day 3-5 of each treatment cycle |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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|
| 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 |
|
| 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 |
| Incidence of significant laboratory events | Up to 4 weeks after last treatment cycle |
| Number of perforations, ulcerations and/or bleedings (PUB) of the upper gastro-intestinal tract | Up to 4 weeks after last treatment cycle |
| Number of gastro-intestinal adverse events (GI-AEs) | Up to 4 weeks after last treatment cycle |
| Duration of hospitalization stay due to GI-AEs | Up to 4 weeks after last treatment cycle |
| Number of additional visits at physician due to GI-AEs | Up to 4 weeks after last treatment cycle |
| Duration of hospitalization due to drug related AEs | Up to 4 weeks after last treatment cycle |
| Number of withdrawals due to AEs | Up to 4 weeks after last treatment cycle |
| Intensity of AEs on a 3-point scale | Up to 4 weeks after last treatment cycle |
| Evaluation of labor and/or daily life disability associated with dysmenorrhea on a VAS | Baseline and day 3-5 of each treatment cycle |
| Change in severity of symptomatology associated with dysmenorrhea | Baseline and day 3-5 of each treatment cycle |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D008528 | Mefenamic Acid |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054361 | Fenamates |
| D062367 | ortho-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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