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NCT03611101 · ClinicalTrials.gov registry record
Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials
A clinical trial, sponsored by Meridian Bioscience.
- Completed
- Registry status
- 124
- Enrollment target
NCT03611101: Completed study, sponsored by Meridian Bioscience.
NCT03611101 is a clinical trial that has completed, run by Meridian Bioscience. The registered enrollment target is 124 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03611101 has completed, sponsored by Meridian Bioscience.
- COMPLETED
- Registry status
- 124 participants
- Enrollment target
Study Summary
This is a companion study assessing the ¹³C-Methacetin Breath Test (MBT) in subjects participating in the Bristol Myers-Squibb (BMS) NCT03486899 and NCT03486912 referenced studies using study drug BMS-986036.
Primary Outcome
Identification of subjects that experience a change in metabolic capacity in each of the treatment arms versus placebo arm after 48 weeks compared to baseline as determined independently by the Methacetin Breath Test (MBT) PDR peak output parameter under a responder analysis. No actual cut-off values or specific values of percent change criteria were pre-specified since this study was solely exploratory by nature as described in the protocol. The MBT PDR peak parameter was collected and analyzed
Interventions
- DRUG BMS-986036
- COMBINATION_PRODUCT ¹³C-Methacetin Breath Test
- DEVICE BreathID MCS device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2018-05-04 |
| Est. Completion | 2021-11-10 |
What the finished NCT03611101 record still lists
NCT03611101 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which BMS-986036 is the first listed.
NCT03611101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03611101 about?
NCT03611101 is a clinical study titled "Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials". This is a companion study assessing the ¹³C-Methacetin Breath Test (MBT) in subjects participating in the Bristol Myers-Squibb (BMS) NCT03486899 and NCT03486912 referenced studies using study drug BMS-986036.
What is the current status of trial NCT03611101?
This trial is currently completed. The enrollment target is 124 participants. The study started on 2018-05-04. Estimated completion is 2021-11-10.
What interventions are being tested in trial NCT03611101?
The interventions under investigation include: BMS-986036 (DRUG), ¹³C-Methacetin Breath Test (COMBINATION_PRODUCT), BreathID MCS device (DEVICE).
Who is sponsoring clinical trial NCT03611101?
This trial is sponsored by Meridian Bioscience, which has 19 total clinical trials registered on ClinicalTrials.gov.
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