At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 430 enrolled
Drug / intervention
HTX-011A +5 moredrug
Likely dose
Not stated in 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 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011, HTX-002, or HTX-009 for Postoperative Analgesia Following Bunionectomy
In Brief
A Phase 2 clinical trial evaluating HTX-011A, Saline Placebo, and 4 other interventions for Postoperative Pain and Bunions. Completed, enrolled 430 participants across 5 sites.
Detailed Summary
A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain, Bunions
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMay 2016
First PostedMay 2016
Primary CompletionFeb 2017
Study CompletionMar 2017
TodayJul 2026
First PostedMay 5, 2016
Enrollment StartMay 1, 2016
Primary CompletionFeb 1, 2017
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.2 years ago
Interventions
HTX-011Adrug
HTX-011A (bupivacaine/meloxicam), via injection.
Saline Placebobiological
Saline placebo via injection.
HTX-011Bdrug
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
HTX-002drug
HTX-002, via injection.
Bupivacaine HCldrug
Bupivacaine HCI, via injection.
HTX-009drug
HTX-009, via injection.