Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
Intervention1: Aceclofenac plus Drotaverine: Aceclofenac 100 mg plus Drotaverine 80 mg Fixed dose combination orally twice daily for three days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Ipca Laboratories Ltd
Ms Ipca Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients aged between 18 to 35 years (both inclusive) 2.Patients with normal gynecological examination and normal ultrasound findings of uterus and adnexa 3.Female patients with history of primary dysmenorrhoea characterized by painful spasmodic cramping in the lower abdomen, just before and / or during menstruation (lasting for 8 to 72hrs) 4.Patients should have history of onset of primary dysmenorrhic symptoms within 5 years of menarche 5.Patient should have painful menses in at least 4 of previous 6 menstrual cycles 6.Patients reporting a pain intensity of more than or equals to 6 on a 11 point Pain Intensity Numerical Rating Scale (PINRS) 7.Patients should have history of regular menstrual cycles 8.Patients agree to participate and follow up in the study
Exclusion criteria
Exclusion criteria: 1.Patients with history or presence of recurrent pelvic or lower abdominal pain outside the menstrual period or have dysmenorrhoea secondary to endometriosis, adenomyosis, uterine myomas, endometrial polyps, cervical stenosis or pelvic inflammatory disease 2.Patients with disease or history of abnormalities of the reproductive organs confirmed by clinical examination and ultrasound. 3.Patients with presence or history of using intrauterine devices or oral/injectable contraceptives within 6 months 4.Patients receiving NSAIDs for any other condition or with history of intake within 48 hours prior to study 5.Patients with history of peptic ulcer disease, severe gastritis, gastrointestinal bleeding or any other significant comorbidity which may interfere in the study as per the Investigator s opinion 6.Patients with history of hypersensitivity to drotaverine or NSAIDs 7.Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To document the real life safety and tolerability of Aceclofenac (100 mg) plus Drotaverine (80 mg) tabletsTimepoint: Baseline to End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in pain intensity scoreTimepoint: 0, 2, 4, 8, 24, 48, 72 hours;Mean change in pain relief scoreTimepoint: 2, 4, 8, 24, 48, 72 hours;Patients and Physician global impression on study drug effectivenessTimepoint: End of Study;Proportion of Patients requiring rescue medicationTimepoint: End of Study | — |
Countries
India
Contacts
Public ContactNitin Chandurkar
Ipca Laboratories Limited
Outcome results
None listed