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Postoperative Nausea and VomitingPhase 2NCT00108095

A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

A Phase 2 study testing intravenous ondansetron in people with Postoperative Nausea and Vomiting and Nausea and Vomiting, Postoperative, run by GlaxoSmithKline at 58 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV Read more about this study

Who is it for?
Ages 18 to 55 years, women only
What is being tested?
intravenous ondansetron
Type of treatment
Injection or infusion
How many people
701 participants
Where
58 sitesin 6 countries
Study dates
Oct 2004to Aug 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females age 18-55
  • Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal

Who cannot join

  • Pregnant or breastfeeding
  • Post-menopausal
  • Not undergoing general anesthesia

Trial locations and contacts

58 sites in 6 countries.

58 sites in 6 countries

United States30 sites

  • GSK Investigational Site

    Alpharetta, Georgia, 30005

  • GSK Investigational Site

    Arcadia, California, 91007

  • GSK Investigational Site

    Baltimore, Maryland, 21229-5299

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70806

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Duarte, California, 91010

  • GSK Investigational Site

    Glendale, California, 91206

  • GSK Investigational Site

    Houston, Texas, 77024

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77054

  • GSK Investigational Site

    Hutchinson, Kansas, 67502

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Kansas City, Kansas, 66160

  • GSK Investigational Site

    Laguna Hills, California, 92653

  • GSK Investigational Site

    Loma Linda, California, 92354

  • GSK Investigational Site

    Montgomery, Alabama, 36106

  • GSK Investigational Site

    Naples, Florida, 34108

  • GSK Investigational Site

    New Brunswick, New Jersey, 8903

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    New York, New York, 10025

  • GSK Investigational Site

    Pasadena, California, 91109

  • GSK Investigational Site

    Pensacola, Florida, 32504

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    San Antonio, Texas, 78240

  • GSK Investigational Site

    San Diego, California, 92123

  • GSK Investigational Site

    Stanford, California, 94305

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    Winchester, Virginia, 22601

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada14 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 2T9

  • GSK Investigational Site

    Edmonton, Alberta, T5H 3V9

  • GSK Investigational Site

    Halifax, Nova Scotia, B3K 6R8

  • GSK Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • GSK Investigational Site

    London, Ontario, N6A 4G5

  • GSK Investigational Site

    London, Ontario, N6A 4V2

  • GSK Investigational Site

    Montreal, Quebec, H3A 1A1

  • GSK Investigational Site

    Québec, Quebec, G1L 3L5

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • GSK Investigational Site

    Ste-Foy, Quebec, G1V 4G2

  • GSK Investigational Site

    Toronto, Ontario, M5T 2S8

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 3C6

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Hungary4 sites

  • GSK Investigational Site

    Győr, 9023

  • GSK Investigational Site

    Kistarcsa, 2143

  • GSK Investigational Site

    Miskolc, 3529

  • GSK Investigational Site

    Székesfehérvár, 8001

Other trials in Hungary

Spain4 sites

  • GSK Investigational Site

    Cadiz, 11009

  • GSK Investigational Site

    Cartagena, 30203

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Santiago de Compostela, 15706

Other trials in Spain

Belgium3 sites

  • GSK Investigational Site

    Aalst, 9300

  • GSK Investigational Site

    Braasschaat, 2930

  • GSK Investigational Site

    Brussels, 1020

Other trials in Belgium

Germany3 sites

  • GSK Investigational Site

    Aachen, North Rhine-Westphalia, 52074

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56073

  • GSK Investigational Site

    Marburg, Hesse, 35043

Other trials in Germany

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW679769, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting (PONV) and Post-discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV Who Are Undergoing Surgical Procedures Associated With an Increased Emetogenic Risk

This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both safety and effectiveness in prevention PONV

Read the detailed description

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW67969, When Administered With Intravenous Ondansetron Hydrochloride for the Prevention of Post-Operative Nausea and Vomiting (PONV) and Post-Discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV Who Are Undergoing Surgical Procedures Associated With an Increased Emetogenic Risk

Being tested
intravenous ondansetron
Keywords
emesis, nausea, post operative nausea and vomiting, vomiting, PONV
Medical subject headings
Postoperative Nausea and Vomiting, Vomiting, Nausea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intravenous ondansetronDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia

Secondary outcomes (2)

  1. Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia

  2. The extent of nausea experienced by subjects.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionAug 2005
  4. Study completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
701 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00108095
Sponsor's protocol ID
NKT102260
Status last verified
Jan 2017
First submitted
13 Apr 2005
Last updated
20 Jan 2017
Results posted
No

Publications

  • Singla NK, Singla SK, Chung F, Kutsogiannis DJ, Blackburn L, Lane SR, Levin J, Johnson B, Pergolizzi JV Jr. Phase II study to evaluate the safety and efficacy of the oral neurokinin-1 receptor antagonist casopitant (GW679769) administered with ondansetron for the prevention of postoperative and postdischarge nausea and vomiting in high-risk patients. Anesthesiology. 2010 Jul;113(1):74-82. doi: 10.1097/ALN.0b013e3181d7b13a.

    PubMed 20526194

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing intravenous ondansetron in people with Postoperative Nausea and Vomiting and Nausea and Vomiting, Postoperative, run by GlaxoSmithKline at 58 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Canada, Hungary, Spain, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00108095, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.

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