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 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
NCT ID:
NCT06090461
Eligibility Criteria:
For the main objective (1.0, 1.1), patients are eligible if they meet the following Inclusion Criteria:
* Have at least one prescription for NB between September 2014 and February 2020, including concurrent prescriptions (within 15 days) for naltrexone and bupropion; or have at least one prescription for lorcaserin;
* Have at least 180 days of data available prior to cohort entry with no evidence of prescriptions or dispensings of NB or lorcaserin;
* Have at least one BMI value available in the 180 days prior to cohort entry, inclusive of the index date;
* Have documentation of at least one outpatient medical visit 180 or more days prior to cohort entry, and at least one healthcare interaction in the 180 days prior to cohort entry;
* Are at least 18 years of age on the cohort entry date.
For the main objective, patients are not eligible if they have a diagnosis of any of the following conditions in the 180 days before the cohort entry date:
* Epilepsy;
* Bulimia;
* Anorexia nervosa;
* Surgical procedure for weight loss.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06090461
Study Brief:
Protocol Section:
NCT06090461