Injectable Diclofenac for the Prevention of Post-operative Dental Pain
NCT ID: NCT01706588
Last Updated: 2014-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2013-01-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Diclofenac sodium 5 mg/mL
Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Diclofenac sodium 12.5 mg/mL
Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Diclofenac sodium 25 mg/mL
Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Diclofenac sodium 50 mg/mL
Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Placebo 1 mL
Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Interventions
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Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients aged ≥ 18 to ≤ 65 years old.
3. Subjects able and willing to give their written consent prior to inclusion in the study.
4. Female subjects of childbearing potential must (1) have a negative urine pregnancy test at the inclusion visit, (2) be using an appropriate method of contraception according to the definition of Note of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner), and (3) be willing to continue using the contraceptive method throughout the entire study period.
5. Subjects must (1) be able to comprehend the full nature and purpose of the study, including possible risks and side effects, (2) fully co-operate with the Investigator, (3) comply with the requirements of the entire study.
6. Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.
Exclusion Criteria
1. Patients refusing to give written informed consent.
2. Patients not able to understand the purposes of the study or not willing to return for the control visits.
3. Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
4. Patients enrolled in any clinical trial in the previous 3 months.
5. Employees of the study centre with direct involvement in the proposed study or other studies under the direction of the main investigator or study centre, as well as family members of the employees or investigator.
6. Pregnant or breast-feeding women.
7. Alcohol or drug abuse in the previous 12 months.
8. Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.
18 Years
65 Years
ALL
No
Sponsors
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IBSA Institut Biochimique SA
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Dietrich, MD
Role: PRINCIPAL_INVESTIGATOR
The School of Dentistry, University of Birmingham
Locations
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The School of Dentistry University of Birmingham
Birmingham, , United Kingdom
Countries
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References
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Gorecki P, Rainsford KD, Taneja P, Bulsara Y, Pearson D, Saund D, Ahmed B, Dietrich T. Submucosal Diclofenac for Acute Postoperative Pain in Third Molar Surgery: A Randomized, Controlled Clinical Trial. J Dent Res. 2018 Apr;97(4):381-387. doi: 10.1177/0022034517744207. Epub 2017 Dec 4.
Other Identifiers
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12UK/DCsc04
Identifier Type: -
Identifier Source: org_study_id
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