Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
NCT ID:
NCT03467932
Pre Assignment Details:
After screening, patients underwent a 2-week, single-blind placebo run-in period (Visits 1\[baseline\] and 2), followed by a 12-week treatment period.
Cohort A:
12-wk treatment period, 2 parts. Part 1, dose escalation interval for 2 weeks (Visits 3 and 4) Part 2, stable dose "maintenance" for 10 weeks (Visits 5-9).
;
Cohort B:
12-wk treatment period, 2 parts. Part 1, stable dosing for 2 weeks (Visits 3 and 4) Part 2, stable dosing for 10 weeks, Visits 5-9).
Recruitment Details:
Patients were recruited into two primary Cohorts, A and B.
Cohort A:
1. ORMD-0801 1X daily
2. ORMD-0801 2X daily
3. ORMD-0801 3X daily
4. Matched Placebo
Sub-Cohort A 20 subjects Per FDA, excipient matched placebo; randomized single-blind, TID, same schedule as for Cohort A.
Not part of primary analysis.
Cohort B:
1. ORMD-0801 8 mg 1X daily
2. ORMD-0801 8 mg 2X daily
3. ORMD-0801 16 mg 1X daily
4. ORMD-0801 16 mg 2X daily
5. Excipient matched placebo once daily
Study:
NCT03467932
Study Brief:
Results Section:
NCT03467932