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COMPLETED Phase 2

Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV)

NCT00895830 · View on ClinicalTrials.gov ↗

Study Summary

To assess the efficacy and safety of different doses of APD405 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.

Interventions

  • DRUG Placebo
  • DRUG APD405

Study Locations (18)

Other

  • University Hospital — Besançon
  • Hôpital mère enfant — Bron
  • Hôpital Huriez — Lille
  • University Hospital — Nancy
  • Hôpital FOCH — Paris
  • University Hospital — Reims
  • Hautepierre Hospital — Strasbourg
  • Charité - Universitätsmedizin — Berlin
  • Universität Heidelberg — Heidelberg
  • University of Leipzig — Leipzig
  • Klinikum Ludwigshafen — Ludwigshafen
  • Philipps University — Marburg
  • University Hospitals of Würzburg — Würzburg
  • Geneva University Hospitals — Geneva
  • Centre Hospitalier Universitaire Vaudois — Lausanne

California

  • UCSF Medical Center at Mt Zion — San Francisco

North Carolina

  • Duke University Medical Center — Durham

Texas

  • Memorial Hermann-Memorial City Hospital — Houston

Trial Details

FieldValue
Enrollment Target 257 participants
Start Date 2009-05
Est. Completion 2009-11
Phase Phase 2

Sponsor

Acacia Pharma

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00895830

The ClinicalTrials.gov registry entry for NCT00895830 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 257 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acacia Pharma, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Postoperative Nausea and Vomiting appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00895830 reports 18 study locations spanning 4 distinct geographic areas — top geographies include Other, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00895830 about?

NCT00895830 is a clinical study titled "Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV)". To assess the efficacy and safety of different doses of APD405 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), cholecystec...

What is the current status of trial NCT00895830?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 257 participants. The study started on 2009-05. Estimated completion is 2009-11.

What conditions does trial NCT00895830 study?

This clinical trial studies the following conditions: Postoperative Nausea and Vomiting. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00895830?

The interventions under investigation include: Placebo (DRUG), APD405 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00895830?

This trial is sponsored by Acacia Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00895830 being conducted?

This trial has 18 study locations across California, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial