CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 215 enrolled
Drug / intervention
APD421 +1 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.

Search/NCT01510704
NCT01510704Phase 2Completed

Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting

Acacia Pharma Ltd·interventional·Posted Jan 16, 2012·Updated Mar 5, 2019

In Brief

A Phase 2 clinical trial evaluating APD421 and Placebo for Postoperative Nausea and Vomiting. Completed, enrolled 215 participants across 13 sites in 3 countries.

Detailed Summary

To assess the efficacy and safety of different doses of APD421 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2012
Enrollment StartJan 1, 2012
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.5 years ago

Interventions

APD421drug

IV

Placebodrug

IV