At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 221 enrolled
Drug / intervention
Sebacoyl Dinalbuphine Ester +1 moredrug
Likely dose
Sebacoyl Dinalbuphine Ester 2mLfrom 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 Randomized, Double Blind, Placebo-Controlled, Single Dose Study to Assess The Safety and Efficacy of Intramuscular Sebacoyl Dinalbuphine Ester (SDE) for Post-Hemorrhoidectomy Pain Management
In Brief
A Phase 3 clinical trial evaluating Sebacoyl Dinalbuphine Ester and Placebo for Analgesia Disorder and Pain. Completed, enrolled 221 participants across 6 sites.
Detailed Summary
This is a randomized, double blind, placebo-controlled, single dose study to assess the safety and efficacy of intramuscular sebacoyl dinalbuphine ester (SDE) for post-hemorrhoidectomy pain management.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnalgesia Disorder, Pain
CountriesTaiwan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2012
Primary CompletionApr 2015
First PostedJun 2015
TodayJul 2026
First PostedJun 10, 2015
Enrollment StartDec 1, 2012
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.1 years ago
Interventions
Sebacoyl Dinalbuphine Esterdrug
Intramuscular injection 2mL/vial (75mg/mL)
Placebodrug
Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial