Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to evaluate the safety of an association with one anti-inflammatory and one gastroprotective agent compared to the anti-inflammatory monotherapy in patients with acute or chronic osteoarticular inflammation. |
|---|---|
| Condition | Acute and Chronic Inflammation Dyspepsia |
| Intervention | Drug: Nimesulide + Pantoprazole Drug: Nimesulide |
| Phase | Phase 3 |
| Sponsor | EMS |
| Responsible Party | EMS |
| ClinicalTrials.gov Identifier | NCT01670552 |
| First Received | August 17, 2012 |
| Last Updated | September 24, 2013 |
| Last verified | September 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 17, 2012 |
|---|---|
| Last Updated Date | September 24, 2013 |
| Start Date | October 2013 |
| Estimated Primary Completion Date | September 2014 |
| Current Primary Outcome Measures | Comparison of endoscopic and histological changes of the upper gastrointestinal tract [Time Frame: 7 days] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Incidence of adverse events and dyspeptic complaints during the study [Time Frame: 7 days] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients |
|---|---|
| Official Title | Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients. |
| Brief Summary | The purpose of this study is to evaluate the safety of an association with one anti-inflammatory and one gastroprotective agent compared to the anti-inflammatory monotherapy in patients with acute or chronic osteoarticular inflammation. |
| Detailed Description | - Double-blind,randomized, multicenter - Experiment duration: 8 days - 03 visits (day 0 - screening), (day 1 - randomization), (day 7 - closure) - Evaluate the safety of an association with one anti-inflammatory and one gastroprotective compared to anti-inflammatory monotherapy in patients with acute or chronic osteoarticular inflammation - Adverse events evaluation |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Nimesulide + Pantoprazole 1 tablet each 12 hours for 7 days Drug: Nimesulide 1 tablet each 12 hours for 7 days |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 206 |
| Estimated Completion Date | September 2014 |
| Estimated Primary Completion Date | June 2014 |
| Eligibility Criteria | Inclusion Criteria: - Adults male or female aged ≥ 18 years old; - Comply with all the purposes and procedures of the study by signing and dating the IC - Acute or chronic osteo-articular injury in need of of anti-inflammatory for a period of 7 days - Upper endoscopy with normal or non-erosive esophagitis or gastritis endoscopic enanthematous. Exclusion Criteria: - Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period History of peptic ulcer or gastric surgery; - Use of Non-steroidal anti-inflammatory (NSAIDs), aspirin, proton pump inhibitor (PPIs), H2 blocker and antacid in the past 30 days; - Upper endoscopy with erosive lesions or ulcerated lesions of the esophagus, stomach and / or duodenum; - Contraindication to the use of NSAIDs or PPIs; - Renal or hepatic impairment; |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01670552 |
|---|---|
| Other Study ID Numbers | NIPEMS1111 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | EMS |
| Study Sponsor | EMS |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | September 2013 |