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NCT03797703 · ClinicalTrials.gov registry record · Phase 1
Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT03797703: Completed Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT03797703 is a Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03797703, a Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a prospective study to assess the utility of Lidocaine Hydrochloride 2% gel enema (Hi-Tech Pharmacal Co., Inc.) in reducing post-procedural pain after endoscopic band ligation of internal hemorrhoids. Briefly, patients will be consented prior to entry into the study. During the endoscopic band ligation procedure, patients will be blindly placed into the treatment arm or control arm. The treatment arm will receive 15 ml enema of lidocaine gel immediately upon cessation of the procedure. In the placebo arm, oral pain medications will be provided. Researchers will assess pain following the procedure at 1 hour, 24 hours and 48 hours via telephone call. Another telephone call will be performed at 72 to 96 hours to assess any side effects of the medication.
Primary Outcome
This effect will be measured by statistical analysis comparing the treatment groups numeric pain scale ratings (0-10) with the control groups numeric pain scale ratings (0-10).
Interventions
- DRUG Lidocaine Hydrochloride 2% gel enema
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2018-11-26 |
| Est. Completion | 2020-06-05 |
| Phase | Phase 1 |
What the finished NCT03797703 record still lists
NCT03797703 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 1 intervention - of which Lidocaine Hydrochloride 2% gel enema is the first listed.
NCT03797703 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03797703 about?
NCT03797703 is a clinical study titled "Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain". This is a prospective study to assess the utility of Lidocaine Hydrochloride 2% gel enema (Hi-Tech Pharmacal Co., Inc.) in reducing post-procedural pain after endoscopic band ligation of internal hemorrhoids. Briefly, patients will be consented prior to entry into the study. During the endoscopic ba...
What is the current status of trial NCT03797703?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2018-11-26. Estimated completion is 2020-06-05.
What interventions are being tested in trial NCT03797703?
The interventions under investigation include: Lidocaine Hydrochloride 2% gel enema (DRUG).
Who is sponsoring clinical trial NCT03797703?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03797703's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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