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NCT03789318 · ClinicalTrials.gov registry record · Phase 2
Study in Subjects Undergoing Complete Abdominoplasty
A Phase 2 study of Post-surgical Pain, sponsored by Concentric Analgesics.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT03789318: Completed Phase 2 study of Post-surgical Pain, sponsored by Concentric Analgesics.
NCT03789318 is a Phase 2 study of Post-surgical Pain that has completed, run by Concentric Analgesics. The registered enrollment target is 54 participants, below the 201-participant average among 7 other Post-surgical Pain trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03789318, a Phase 2 study of Post-surgical Pain, has completed, sponsored by Concentric Analgesics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block.
Primary Outcome
Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 96 hours
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Hydromorphone
- DRUG Bupivacaine Hydrochloride
- DRUG Fentanyl
- DRUG CA-008 5 mg
Study Locations (1)
California
- Lotus Clinical Research, LLC - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2018-12-03 |
| Est. Completion | 2019-06-12 |
| Phase | Phase 2 |
What the finished NCT03789318 record still lists
NCT03789318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 201-participant average among 7 other Post-surgical Pain trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Post-surgical Pain appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT03789318 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03789318 about?
NCT03789318 is a clinical study titled "Study in Subjects Undergoing Complete Abdominoplasty". Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block.
What is the current status of trial NCT03789318?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2018-12-03. Estimated completion is 2019-06-12.
What conditions does trial NCT03789318 study?
This clinical trial studies the following conditions: Post-surgical Pain.
What interventions are being tested in trial NCT03789318?
The interventions under investigation include: Placebo (DRUG), Hydromorphone (DRUG), Bupivacaine Hydrochloride (DRUG), Fentanyl (DRUG), CA-008 5 mg (DRUG).
Who is sponsoring clinical trial NCT03789318?
This trial is sponsored by Concentric Analgesics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03789318 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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