European Phase III Study of APD421 in PONV

NCT01991821 | Completed Phase 3 Results

• 1 other identifier: DP10014
• Study Type: interventional
• Target: 368
• Locations: 2 countries
• Sites: 2

Brief Summary

A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

Conditions

PONV

Outcome Measures

Primary Outcomes (1)

• Complete Response (no Emesis, Significant Nausea or Rescue Medication)

  The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%.

  24 hours after end of surgery

Secondary Outcomes (6)

• Complete Response (no Emesis or Rescue Medication)

  24 hrs after end of surgery

• Total Response (no Emesis, Nausea or Rescue Medication)

  24 hrs after end of surgery

• Incidence of Emesis (Vomiting/Retching)

  24 hours after end of surgeryry

• Incidence of Nausea

  24 hours after end of surgery

• Incidence of Significant Nausea

  24 hours after end of surgery

Study Arms (2)

APD421

EXPERIMENTAL

IV APD421 single dose

Drug: APD421

Placebo

PLACEBO COMPARATOR

IV placebo single dose

Drug: Placebo

Interventions

APD421 DRUG

APD421

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years of age
• Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital

You may not qualify if:

• Patients scheduled for outpatient/day case surgery
• Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery
• Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
• Patients who are expected to remain ventilated for a period after surgery
• Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed

Sponsors & Collaborators

• Acacia Pharma Ltd: lead

Study Sites (2)

CHU de Hautepierre

Strasbourg, France

Location

University Hospitals of Würzburg

Würzburg, Germany

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Limitations and Caveats

There are no limitations and caveats with this study.

Results Point of Contact

• Title: Dr Gabriel Fox
• Organization: Acacia Pharma

GabrielFox@acaciapharma.com

01223875130

Study Officials

• Pierre Diemunsch, MD

  Hôpital de Hautepierre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 25, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 20, 2019
• Results First Posted: August 2, 2019

Record last verified: 2019-08

Locations

DE (1); FR (1)