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:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT01361568
Eligibility Criteria:
Inclusion Criteria:
* Able to provide written informed consent prior to any study procedures;
* Able to communicate clearly with the Investigator and staff;
* Female between 21 and 65 years of age, inclusive;
* Scheduled for elective laparoscopic hysterectomy under general anesthesia;
* Negative result on serum pregnancy test at screening and negative urine pregnancy test at Baseline (for women of child-bearing potential only) and not currently breast feeding, or planning to do so within 30 days of dosing;
* Negative urine drug screen for drugs of abuse at Screening and at Baseline;
* American Society of Anesthesiologists (ASA) risk class of I to III;
* Body mass index (BMI) between 17 and 40 inclusive.
Exclusion Criteria:
* Has known allergies to opioids, or hypersensitivity to other materials (such as infusion line) or medications to be used in the study;
* Has a known or suspected history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)-diagnosed alcohol, opiate or other drug abuse or dependence within 12 months prior to screening;
* Is unable to refrain from alcohol consumption for a period beginning 24 hours prior to surgery through the end of the Treatment Period;
* Is scheduled to undergo a hysterectomy that will utilize any type of robotic technology and/or a concomitant surgical procedure that would produce a significantly greater degree of surgical trauma than the laparoscopic hysterectomy or laparoscopic assisted vaginal hysterectomy alone;
* Has taken non-opioid analgesics (including cyclooxygenase-2 \[COX-2\] inhibitors) or nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 hours of the Baseline assessments;
* Has taken any opioid analgesics or used systemic steroids within 4 days of surgery OR has previously used opiates chronically for a period of ≥3 months;
* Has used antipsychotics, antiepileptics, sedatives, hypnotics, or antianxiety agents, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants for \< 30 days prior to surgery or had a dose change within the previous 30 days;
* Has taken any prescription or over-the-counter medication within 3 days prior to surgery that, in the opinion of the Investigator, is expected to confound the analgesic response;
* Has taken herbal agents or nutraceuticals (i.e., chaparral, comfrey, germander, gin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian) 7 days prior to surgery;
* In the opinion of Investigator shows clinical signs of hypovolemia;
* Has an oxygen saturation \< 92% on room air at Screening or prior to receiving the first infusion of study drug;
* Has any history of clinically significant cardiovascular disease,
* Has a clinically significant abnormal electrocardiogram (ECG) or a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);
* Has a history of any serious medical conditions that in the opinion of the Investigator would preclude study participation;
* Has serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, or gamma glutamyl transferase (GGT) \>2.5 x the upper limit of normal (ULN) at screening;
* Has bilirubin, blood urea nitrogen (BUN), or creatinine \>1.5 x the reference ULN at Screening;
* Has abnormally low hemoglobin \< 10 mg/dl at Screening;
* Has serum sodium levels \> 146 mmol/L at Screening;
* Has impaired renal function (creatinine clearance \[CrCl\] \< 50 ml/min) at Screening;
* Has a positive test for human immunodeficiency virus (HIV) or known history of HIV infection;
* Has received another investigational drug within 30 days of scheduled surgery;
* Has a significant chronic pain condition in areas unrelated to the operative site at the time of Screening that in the Investigator's opinion could confound the interpretation of study results
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01361568
Study Brief:
Protocol Section:
NCT01361568