Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00952133
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Has a known hypersensitivity or contraindication to palonosetron hydrochloride or any another 5-HT3 receptor antagonist, dexamethasone, or any scheduled anesthetic or analgesic agents
* Has a known hypersensitivity to fentanyl and/or ketorolac tromethamine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00952133
Study Brief:
Protocol Section:
NCT00952133