Back to resultsStudy Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
Primary Purpose
Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
effervescent ibuprofen tablets
effervescent Aspirin plus Vitamin C tablets
ibuprofen tablets
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring dental pain, analgesic, NSAID, ibuprofen, aspirin
Eligibility Criteria
Inclusion:
- Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
- In general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone)
- Use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide
Exclusion:
- Presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function)
- Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation
- Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically-approved method of contraception
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Sum of pain relief and pain intensity difference scores
Secondary Outcome Measures
Time to meaningful pain relief
Full Information
NCT ID
NCT00631111
First Posted
February 28, 2008
Last Updated
July 10, 2009
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00631111
Brief Title
Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
Official Title
Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
dental pain, analgesic, NSAID, ibuprofen, aspirin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
effervescent ibuprofen tablets
Intervention Type
Drug
Intervention Name(s)
effervescent Aspirin plus Vitamin C tablets
Intervention Type
Drug
Intervention Name(s)
ibuprofen tablets
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Sum of pain relief and pain intensity difference scores
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Time to meaningful pain relief
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion:
Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
In general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone)
Use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide
Exclusion:
Presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function)
Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation
Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically-approved method of contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
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