Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV

NCT00952133 | Completed Phase 4 Results

• 1 other identifier: H08-605
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if subjects who receive Palonosetron plus Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive Palonosetron alone.

Conditions

PONV

Keywords

PONV; Outpatient surgery; Laparoscopic abdominal surgery; Laparoscopic gynecologic surgery

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  A Complete Response (CR): defined as no nausea, no vomiting/retching, no rescue medication and no withdrawal of consent from the time of administration of the study drug(s) until 72 hours post emergence from anesthesia.

  Pre-op through 72 hours post emergence from anesthesia

Secondary Outcomes (1)

• Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery

  Pre-op through 96 hours post-op

Study Arms (2)

Palonosetron with Dexamethasone

EXPERIMENTAL

Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.

Drug: Palonosetron with Dexamethasone

Palonosetron only

PLACEBO COMPARATOR

Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution

Drug: Palonosetron only

Interventions

Palonosetron only DRUG

The placebo arm will be given a dose of IV palonosetron only, and saline solution prior to surgery to see how this compares with the other combination.

Also known as: Palonosetron, Saline Solution

Palonosetron only

Palonosetron with Dexamethasone DRUG

Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery to see if this reduces PONV.

Also known as: Palonosetron, Aloxi, Dexamethasone, Decadron

Palonosetron with Dexamethasone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Has signed an informed consent form
• Have an American Society of Anesthesiologists (ASA) Physical Status Classification of I, II, or III
• Female, 18-55 years old
• surgically sterilized, or
• pre-menopausal, with a negative pregnancy test within 7 days before study medication administration
• Male, 18-55 years old, who has more than 3 risk factors for PONV
• Undergoing outpatient laparoscopic gynecological surgery or laparoscopic abdominal surgery, scheduled for between 1 and 3 hours duration
• Known to have a history of post-operative nausea and vomiting and/or a history of motion sickness
• Has been a non-smoker for at least the previous 12 consecutive months
• Is able and willing to complete a subject diary until the end of the 96 Hour Follow-Up Assessment period
• Will be available to respond to follow-up by study personnel at 72 and 96 hours post emergence from anesthesia

You may not qualify if:

• Has an ASA Physical Status Classification of IV or V
• Is pregnant or breastfeeding
• Has been taking more than 10-15mg of oxycodone, or an equivalent opioid dose, on a regular, daily basis, for more than 3 consecutive days before surgery
• Has received an investigational drug in the precious 30 days or who is schedule to receive any investigational drug during the study period
• Has persistent or recurrent nausea and/or vomiting due to other etiologies, including but not limited to, gastric outlet obstruction, hypercalcemia, active peptic ulcer, increased intracranial pressure, or brain metastases
• Experienced retching or vomiting or uncontrolled nausea within 48 hours before administration of study drug
• Received medication with known or potential antiemetic activity within 24 hours before receiving study drug. This includes, but is not limited to: phenothiazines, butyrophenones, hydroxyzine, lorazepam, cannabinoids, metoclopramide, corticosteroids (with the exception of topical steroids for skin disorder and inhaled steroids for respiratory disorders), trimethobenzamide, monoamine oxidase inhibitors, lithium, and 5-HT3 receptor antagonists. Subjects who might require one or more of these medications during the 24-hour treatment period, other than as described in this protocol, are also excluded.
• Note: benzodiazepines other than lorazepam are allowed within 24 hours before and during study period, but only when used for indications such as anxiety or to induce sleep.
• Received radiation therapy to abdomen or pelvis in the 7 days prior to receiving study medication and/or will receive radiation therapy to abdomen or pelvis in the evaluation period.
• Has a history of poorly controlled diabetes mellitus
• Has a history of wound dehiscence
• Has had an incidence of necrotizing fasciitis, or any similar infectious process, within the previous 90 days
• Has a know systemic fungal infection, history of tuberculosis, or other mycobacterial infection
• Is immunocompromised - defined as a white blood cell (WBC) count of \<3,000 mm3
• Has any current or past medical condition (e.g., vagotomy) and/or require medication to treat a condition that could confound the evaluation of the data collected in this clinical trail

Sponsors & Collaborators

• NYU Langone Health: lead
• Eisai Inc.: collaborator

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (1)

• Blitz JD, Haile M, Kline R, Franco L, Didehvar S, Pachter HL, Newman E, Bekker A. A randomized double blind study to evaluate efficacy of palonosetron with dexamethasone versus palonosetron alone for prevention of postoperative and postdischarge nausea and vomiting in subjects undergoing laparoscopic surgeries with high emetogenic risk. Am J Ther. 2012 Sep;19(5):324-9. doi: 10.1097/MJT.0b013e318209dff1.

  PMID: 21519222 RESULT

Related Links

• pubmed abstract

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Palonosetron; Saline Solution; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Jeanna Blitz, MD
• Organization: NYU Langone Medical Center

jeanna.viola@nyumc.org

212-263

Study Officials

• Jeanna Blitz, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: August 4, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: April 1, 2011
• Last Updated: April 17, 2015
• Results First Posted: March 31, 2014

Record last verified: 2015-03

Locations

US (1)