At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 117 enrolled
Drug / intervention
Sirdalud® 2 mg tablets administered +1 moredrug
Likely dose
Sirdalud® 2 mg tablets administeredfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Randomized Study to Assess the Efficacy and Safety of 0,5 mg Tizaspray® Administered Intranasally Versus Sirdalud® 2 mg Tablets, in Patients With Acute Low Back Pain
In Brief
A Phase 3 clinical trial evaluating Tizaspray® administered intranasally and Sirdalud® 2 mg tablets administered for Low Back Pain. Completed, enrolled 117 participants across 1 site.
Detailed Summary
Open label, randomized, controlled, multicenter study with two parallel groups of patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesRomania
CollaboratorsOpera CRO, a TIGERMED Group Company, Latis S.r.l.
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedOct 2016
Primary CompletionJan 2017
Study CompletionFeb 2017
TodayJul 2026
First PostedOct 14, 2016
Enrollment StartOct 1, 2016
Primary CompletionJan 1, 2017
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.7 years ago
Interventions
Tizaspray® administered intranasallydevice
0,5 mg Tizaspray® administered intranasally
Sirdalud® 2 mg tablets administereddrug
Sirdalud® 2 mg tablets administered in patients with acute low back pain