Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain
Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Dental Pain Model
2 other identifiers
interventional
135
1 country
2
Brief Summary
The aim of the study is to evaluate the therapeutic efficacy and safety of two different paracetamol-containing solutions in postoperative dental pain. They will be compared to placebo (a dummy treatment which contains no active ingredient).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2006
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 29, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedAugust 11, 2011
August 1, 2011
11 months
November 29, 2006
August 10, 2011
Conditions
Keywords
Study Arms (3)
1
EXPERIMENTAL2
PLACEBO COMPARATOR3
ACTIVE COMPARATORInterventions
1 gm IV
1 gm IV
equivalent volume IV 0.9% sodium chloride (equivalent volume)
Eligibility Criteria
You may qualify if:
- ASA I or II and scheduled for elective surgical extraction of 1 or more impacted mandibular 3rd molars, at least 1 of which must be a fully or partially impacted mandibular 3rd molar requiring mandibular bone removal.
- Moderate or severe pain within 4 hours after the completion of surgery.
You may not qualify if:
- Another acute or chronic painful physical condition
- Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
- Inability to use and understand Visual Analog Scale and Verbal Rating Score
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Dental Hospital of Manchester
Manchester, England, United Kingdom
University Dental Hospital NHS Trust Cardiff
Cardiff, Wales, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Keyvan Tadjalli-Mehr, MD
Baxter Healthcare Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 29, 2006
First Posted
December 4, 2006
Study Start
November 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
August 11, 2011
Record last verified: 2011-08