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NCT01822665 · ClinicalTrials.gov registry record · Phase 4
Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT01822665: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01822665 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01822665, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study evaluated the effect of oral fast-dissolving formulations of paracetamol and ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic examinations were conducted to determine the gastrointestinal damage produced post a 7 day treatment regimen.
Primary Outcome
Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.
Interventions
- OTHER Placebo
- DRUG Ibuprofen
- DRUG Paracetamol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-07 |
| Phase | Phase 4 |
What the finished NCT01822665 record still lists
NCT01822665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01822665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01822665 about?
NCT01822665 is a clinical study titled "Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics". This study evaluated the effect of oral fast-dissolving formulations of paracetamol and ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic examinations were conducted to determine the gastrointestinal damage produced post a 7 day treatment regimen.
What is the current status of trial NCT01822665?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2012-02. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01822665?
The interventions under investigation include: Placebo (OTHER), Ibuprofen (DRUG), Paracetamol (DRUG).
Who is sponsoring clinical trial NCT01822665?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01822665's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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