Health Condition 1: N23- Unspecified renal colic Health Condition 2: K802- Calculus of gallbladder without cholecystitis
Conditions
Interventions
Intervention1: Aceclofenac plus Drotaverine: Aceclofenac 100 mg plus Drotaverine 80 mg Fixed dose combination orally twice daily for five days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Ipca Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged 18 to 65 years (both inclusive) 2.Patients with presence and history of biliary or ureteric colic as confirmed by ultrasound 3.Patients with mild to moderate pain requiring oral therapy 4.Patients with history of at least one episode of colicky pain within 24 hours prior to screening and not requiring hospitalization
Exclusion criteria
Exclusion criteria: 1.Patients with presence of severe or chronic abdominal colic pain requiring parenteral treatment 2.Patients with colic pain other than biliary or ureteric colic 3.Patients with hypersensitivity to Aceclofenac, Drotaverine or to any of the excipients 4.Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticria) in response to ibuprofen, aspirin or other NSAIDs 5.Patients with active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) 6.Patients with history of gastrointestinal bleeding or perforation related to previous NSAID therapy 7.Patients with severe heart failure, hepatic failure and renal failure 8.Patients with presence/history of porphyria 9.Patients with history of active bleedings or bleeding disorders 10.Patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and or cerebrovascular disease 11.Patients with second or third degree atrioventricular block, cardiogenic shock and arterial hypotension 12.Pregnant or lactating women 13.Patients who are on any other prescription analgesics or antispasmodic medications within the previous week before study enrollment 14.Patients with presence history of cognitive impairment, alcohol abuse, psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments 15.Patients with any other clinically significant illness or conditions which may interfere in the inclusion of a patient in the study as per the investigator s opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety, tolerability, and effectiveness of Aceclofenac (100 mg) + Drotaverine (80 mg) tabletsTimepoint: Baseline, Follow Up Visit Day 3 End of the Study Visit Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in pain intensity scoreTimepoint: 0, 2, 4, 8, 24, 48, 72, 96, 120 hours;Mean change in pain relief scoreTimepoint: 2, 4, 8, 24, 48, 72, 96, 120 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