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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT01965704
Eligibility Criteria:
Inclusion Criteria:
* adult female, opioid-dependent for at least 3 weeks prior to delivery.
* adult female, otherwise healthy.
* adult female, age 18-45 years inclusive.
* adult female, signed consent to participate for self and neonate (maternal subject may decide not to receive the study drug but her neonate can still be included in the study).
* neonate, gestational age 37 weeks through 41 weeks and 6 days at birth.
* neonate, corrected QT interval (QTc) from 12-lead electrocardiogram (ECG) less than 480 milliseconds (ms).
Exclusion Criteria:
* adult female, any condition that, in the opinion of the investigator, would compromise the health of the participant (both mother and fetus) or the integrity of the data.
* adult female, known allergy to study drug (ondansetron).
* adult female, screening 12-lead ECG, if done, showing prolonged QTc will stop the mother from receiving any study drug but her neonate can still be included in the study.
* adult female, not dependent on opioids for at least 3 weeks prior to delivery.
* adult female, generally not healthy.
* adult female, age 17 years or less or 46 years of age and older.
* adult female and neonate, the maternal ingestion or administration of ondansetron within 24 hours prior to delivery, for reasons other than study purposes, will exclude the mother and the neonate.
* neonate, preterm or post-term gestational age at delivery.
* neonate, QTc showing results greater than or equal to 480ms on any 12-lead ECG post delivery will stop the dosing of the study drug, but safety follow up will be done if the mother or baby received at least one dose of study drug.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
45 Years
Study:
NCT01965704
Study Brief:
Protocol Section:
NCT01965704