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NCT01082081 · ClinicalTrials.gov registry record · Phase 4
Post-operative Dental Pain Study Comparing Analgesic Efficacy
A Phase 4 study of Post-surgical Dental Pain, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 300
- Enrollment target
- 2
- Study locations
NCT01082081: Completed Phase 4 study of Post-surgical Dental Pain, sponsored by GlaxoSmithKline.
NCT01082081 is a Phase 4 study of Post-surgical Dental Pain that has completed, run by GlaxoSmithKline. The registered enrollment target is 300 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01082081, a Phase 4 study of Post-surgical Dental Pain, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 300 participants
- Enrollment target
- 2
- Study locations
Study Summary
GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol 1000mg vs 500mg . 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 16 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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Paracetamol 500 mg
- DRUG Paracetamol 1000 mg
Study Locations (2)
Texas
- PPD Dental Clinic - Austin
Utah
- Jean Brown Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-03 |
| Phase | Phase 4 |
What the finished NCT01082081 record still lists
NCT01082081 is an interventional study that assigns participants to a tested intervention. The registered 300 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 (42% lower).
The record links to 1 condition, with Post-surgical Dental Pain appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01082081 reports a single indexed study location in Texas, Utah.
Frequently Asked Questions
What is clinical trial NCT01082081 about?
NCT01082081 is a clinical study titled "Post-operative Dental Pain Study Comparing Analgesic Efficacy". GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol 1000mg vs 500mg . 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 NCT01082081?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2009-10. Estimated completion is 2010-03.
What conditions does trial NCT01082081 study?
This clinical trial studies the following conditions: Post-surgical Dental Pain.
What interventions are being tested in trial NCT01082081?
The interventions under investigation include: Placebo (DRUG), Paracetamol 500 mg (DRUG), Paracetamol 1000 mg (DRUG).
Who is sponsoring clinical trial NCT01082081?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01082081 being conducted?
This trial has 2 study locations across Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01082081's enrollment target sits among peer trials
300 269th of 2000 higher than 1,710 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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