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NCT04133519 · ClinicalTrials.gov registry record · NA
Efficacy and Safety of IBS Digital Behavioral Treatment
A NA study of Irritable Bowel Syndrome, sponsored by metaMe Health.
- Completed
- Registry status
- NA
- Development phase
- 378
- Enrollment target
- 1
- Study location
NCT04133519: Completed NA study of Irritable Bowel Syndrome, sponsored by metaMe Health.
NCT04133519 is a NA study of Irritable Bowel Syndrome that has completed, run by metaMe Health. The registered enrollment target is 378 participants, above the 136-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (178% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04133519, a NA study of Irritable Bowel Syndrome, has completed, sponsored by metaMe Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 378 participants
- Enrollment target
- 1
- Study location
Study Summary
A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Two Self-administered behavioral treatments for Adult Subjects with Symptomatic Irritable Bowel Syndrome (IBS).
Primary Outcome
The primary endpoint of this study is abdominal pain intensity. The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their "worst abdominal pain over the past 24-hours". An Abdominal Pain Intensity Responder is defined as a subject whose daily abdominal pain intensity averaged over the 4 weeks post-treatment (weeks 13 through 16) is at least 30% reduced compared to the daily abdominal pain intensity averaged over the 4 weeks pre-t
Conditions Studied
Interventions
- DEVICE Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD)
- DEVICE Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)
Study Locations (1)
California
- Curebase - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 378 participants |
| Start Date | 2019-10-23 |
| Est. Completion | 2021-10-26 |
| Phase | NA |
What the finished NCT04133519 record still lists
NCT04133519 is an interventional study that assigns participants to a tested intervention. The registered 378 participants enrollment target is mid-sized for trials with a published cap, above the 136-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (178% higher).
The record links to 1 condition, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD) is the first listed.
NCT04133519 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04133519 about?
NCT04133519 is a clinical study titled "Efficacy and Safety of IBS Digital Behavioral Treatment". A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Two Self-administered behavioral treatments for Adult Subjects with Symptomatic Irritable Bowel Syndrome (IBS).
What is the current status of trial NCT04133519?
This trial is currently completed. It is a NA study. The enrollment target is 378 participants. The study started on 2019-10-23. Estimated completion is 2021-10-26.
What conditions does trial NCT04133519 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome.
What interventions are being tested in trial NCT04133519?
The interventions under investigation include: Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD) (DEVICE), Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) (DEVICE).
Who is sponsoring clinical trial NCT04133519?
This trial is sponsored by metaMe Health, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04133519 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04133519's enrollment target sits among peer trials
378 4th of 47 higher than 44 of 47 other Irritable Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Irritable Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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