Phase II Dose-ranging Study of APD421 in PONV

Phase 2

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Placebo; Drug: APD421

• Registration Number: NCT01510704
• Lead Sponsor: Acacia Pharma Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-16
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-05-15
• Results First Submitted QC: 2013-05-15
• Results First Posted: 2013-07-18
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Low dose APD421	APD421	1mg dose level
Mid Dose APD421	APD421	5mg dose level
High Dose APD421	APD421	20mg dose level

Primary Outcome Measures

Name	Time	Method
Post-operative Nausea or Vomiting	24 hours

Trial Locations

Locations (12)

University Hospital; 🇫🇷 Nancy, France

Klinikum Ludwigshafen; 🇩🇪 Ludwigshafen, Germany

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Hôpital mère enfant; 🇫🇷 Bron, France

Hôpital Huriez; 🇫🇷 Lille, France

Hôpital FOCH; 🇫🇷 Paris, France

Hautepierre Hospital; 🇫🇷 Strasbourg, France

Universität Heidelberg; 🇩🇪 Heidelberg, Germany

Charité - Universitätsmedizin; 🇩🇪 Berlin, Germany

University Hospitals of Würzburg; 🇩🇪 Würzburg, Germany

HELIOS Klinikum Aue; 🇩🇪 Aue, Germany

Philipps University; 🇩🇪 Marburg, Germany