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NCT01842633 · ClinicalTrials.gov registry record · Phase 3
Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 365
- Enrollment target
NCT01842633: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT01842633 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 365 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01842633, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 365 participants
- Enrollment target
Study Summary
The purpose of this multi-center study is to assess the efficacy of headache relief of new paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type headache (ETTH).
Primary Outcome
SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 4 hours post dose. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180, 180-240 minutes. The range of SPID at 4 hours post dose was from -12 to 4". PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache,
Interventions
- OTHER Placebo
- DRUG Ibuprofen
- DRUG Paracetamol and Caffeine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2013-04-01 |
| Est. Completion | 2015-03-31 |
| Phase | Phase 3 |
Why NCT01842633 stopped before completion
NCT01842633 is an interventional study that assigns participants to a tested intervention. The registered 365 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01842633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01842633 about?
NCT01842633 is a clinical study titled "Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache". The purpose of this multi-center study is to assess the efficacy of headache relief of new paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type headache (ETTH).
What is the current status of trial NCT01842633?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 365 participants. The study started on 2013-04-01. Estimated completion is 2015-03-31.
What interventions are being tested in trial NCT01842633?
The interventions under investigation include: Placebo (OTHER), Ibuprofen (DRUG), Paracetamol and Caffeine (DRUG).
Who is sponsoring clinical trial NCT01842633?
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 NCT01842633's enrollment target sits among peer trials
365 1001st of 2000 higher than 998 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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