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NCT01075243 · ClinicalTrials.gov registry record · Phase 4
Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 401
- Enrollment target
NCT01075243: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01075243 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 401 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01075243, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 401 participants
- Enrollment target
Study Summary
GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 18 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).
Primary Outcome
SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain
Interventions
- DRUG Placebo
- DRUG Paracetamol 1000 mg
- DRUG Paracetamol 650 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 401 participants |
| Start Date | 2009-11 |
| Est. Completion | 2010-03 |
| Phase | Phase 4 |
What the finished NCT01075243 record still lists
NCT01075243 is an interventional study that assigns participants to a tested intervention. The registered 401 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01075243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01075243 about?
NCT01075243 is a clinical study titled "Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy". GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire...
What is the current status of trial NCT01075243?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 401 participants. The study started on 2009-11. Estimated completion is 2010-03.
What interventions are being tested in trial NCT01075243?
The interventions under investigation include: Placebo (DRUG), Paracetamol 1000 mg (DRUG), Paracetamol 650 mg (DRUG).
Who is sponsoring clinical trial NCT01075243?
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 NCT01075243's enrollment target sits among peer trials
401 210th of 2000 higher than 1,790 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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