DysmenorrheaPhase 2NCT02183025
Efficacy and Safety Study of Meloxicam Versus Mefenamic Acid in Patients With Dysmenorrhea
A Phase 2 study testing Meloxicam 7.5 mg, Meloxicam 15 mg and Mefenamic acid 500 mg in people with Dysmenorrhea, run by Boehringer Ingelheim.
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Meloxicam 7.5 mg, Meloxicam 15 mg and Mefenamic acid 500 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 337 participants
- Where
- No sites listed yet
- Study dates
- Jan 1998to Apr 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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/mm3, leucocyte count < 3,000/mm3)
- 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
About this study
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
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
- Conditions
- Dysmenorrhea
- Being tested
- Meloxicam 7.5 mg, Meloxicam 15 mg, Mefenamic acid 500 mg, Placebo matching 7.5 mg meloxicam, Placebo matching 15 mg meloxicam
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam 7.5 mgDrug
Meloxicam 15 mgDrug
Mefenamic acid 500 mgDrug
Placebo matching 7.5 mg meloxicamDrug
Placebo matching 15 mg meloxicamDrug
Placebo matching 500 mg mefenamic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam 7.5 mg | Experimental | Not described Receives: Drug: Meloxicam 7.5 mg; Drug: Placebo matching 15 mg meloxicam; Drug: Placebo matching 500 mg mefenamic acid |
| Meloxicam 15 mg | Experimental | Not described Receives: Drug: Meloxicam 15 mg; Drug: Placebo matching 7.5 mg meloxicam; Drug: Placebo matching 500 mg mefenamic acid |
| Mefenamic acid 1500 mg | Active comparator | 500 mg three times daily Receives: Drug: Mefenamic acid 500 mg; Drug: Placebo matching 7.5 mg meloxicam; Drug: Placebo matching 15 mg meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of severity of lumbar and/or abdominal pain on a visual analogue scale (VAS)
Measured: Baseline and day 3-5 of each treatment cycle
Secondary outcomes (15)
Final global assessment of efficacy by patient on a 4-point scale
Measured: day 3-5 of the second treatment cycle
Final global assessment of efficacy by investigator on a 4-point scale
Measured: day 3-5 of the second treatment cycle
Final global assessment of tolerability by patient on a 4-point scale
Measured: day 3-5 of the second treatment cycle
Final global assessment of tolerability by investigator on a 4-point scale
Measured: day 3-5 of the second treatment cycle
Number of Participants with Adverse Events (AE)
Measured: Up to 4 weeks after last treatment cycle
Incidence of significant laboratory events
Measured: Up to 4 weeks after last treatment cycle
Number of perforations, ulcerations and/or bleedings (PUB) of the upper gastro-intestinal tract
Measured: Up to 4 weeks after last treatment cycle
Number of gastro-intestinal adverse events (GI-AEs)
Measured: Up to 4 weeks after last treatment cycle
Duration of hospitalization stay due to GI-AEs
Measured: Up to 4 weeks after last treatment cycle
Number of additional visits at physician due to GI-AEs
Measured: Up to 4 weeks after last treatment cycle
Duration of hospitalization due to drug related AEs
Measured: Up to 4 weeks after last treatment cycle
Number of withdrawals due to AEs
Measured: Up to 4 weeks after last treatment cycle
Intensity of AEs on a 3-point scale
Measured: Up to 4 weeks after last treatment cycle
Evaluation of labor and/or daily life disability associated with dysmenorrhea on a VAS
Measured: Baseline and day 3-5 of each treatment cycle
Change in severity of symptomatology associated with dysmenorrhea
Measured: Baseline and day 3-5 of each treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJan 1998
- Primary completionApr 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183025
- Sponsor's protocol ID
- 107.191
- Status last verified
- Aug 2018
- First submitted
- 4 Jul 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02183025
- Acronym / sponsor ID
- 107.191
- Conditions
- Dysmenorrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 1998
- Primary completion
- Apr 1999 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meloxicam 7.5 mg | Experimental | Drug: Meloxicam 7.5 mg, Drug: Placebo matching 15 mg meloxicam, Drug: Placebo matching 500 mg mefenamic acid |
| Meloxicam 15 mg | Experimental | Drug: Meloxicam 15 mg, Drug: Placebo matching 7.5 mg meloxicam, Drug: Placebo matching 500 mg mefenamic acid |
| Mefenamic acid 1500 mg | Active comparator | Drug: Mefenamic acid 500 mg, Drug: Placebo matching 7.5 mg meloxicam, Drug: Placebo matching 15 mg meloxicam500 mg three times daily |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meloxicam 7.5 mg | Drug | Meloxicam 7.5 mg |
| Meloxicam 15 mg | Drug | Meloxicam 15 mg |
| Mefenamic acid 500 mg | Drug | Mefenamic acid 1500 mg |
| Placebo matching 7.5 mg meloxicam | Drug | Mefenamic acid 1500 mg, Meloxicam 15 mg |
| Placebo matching 15 mg meloxicam | Drug | Mefenamic acid 1500 mg, Meloxicam 7.5 mg |
| Placebo matching 500 mg mefenamic acid | Drug | Meloxicam 15 mg, Meloxicam 7.5 mg |
Primary outcome
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
15 secondary outcomes
Final global assessment of efficacy by patient on a 4-point scale
Time frame: day 3-5 of the second treatment cycle
Final global assessment of efficacy by investigator on a 4-point scale
Time frame: day 3-5 of the second treatment cycle
Final global assessment of tolerability by patient on a 4-point scale
Time frame: day 3-5 of the second treatment cycle
Final global assessment of tolerability by investigator on a 4-point scale
Time frame: day 3-5 of the second treatment cycle
Number of Participants with Adverse Events (AE)
Time frame: Up to 4 weeks after last treatment cycle
Incidence of significant laboratory events
Time frame: Up to 4 weeks after last treatment cycle
Number of perforations, ulcerations and/or bleedings (PUB) of the upper gastro-intestinal tract
Time frame: Up to 4 weeks after last treatment cycle
Number of gastro-intestinal adverse events (GI-AEs)
Time frame: Up to 4 weeks after last treatment cycle
Duration of hospitalization stay due to GI-AEs
Time frame: Up to 4 weeks after last treatment cycle
Number of additional visits at physician due to GI-AEs
Time frame: Up to 4 weeks after last treatment cycle
Duration of hospitalization due to drug related AEs
Time frame: Up to 4 weeks after last treatment cycle
Number of withdrawals due to AEs
Time frame: Up to 4 weeks after last treatment cycle
Intensity of AEs on a 3-point scale
Time frame: Up to 4 weeks after last treatment cycle
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
Change in severity of symptomatology associated with dysmenorrhea
Time frame: Baseline and day 3-5 of each treatment cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meloxicam 7.5 mg, Meloxicam 15 mg and Mefenamic acid 500 mg in people with Dysmenorrhea, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.