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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00406679 |
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).
Condition | Intervention | Phase |
---|---|---|
Pain, Postoperative |
Drug: Paracetamol (acetaminophen) solution experimental Drug: paracetamol (acetaminophen) sloution commercial Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 135 |
Study Start Date: | November 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Paracetamol (acetaminophen) solution experimental
1 gm IV
|
2: Placebo Comparator |
Drug: placebo
equivalent volume IV 0.9% sodium chloride (equivalent volume)
|
3: Active Comparator |
Drug: paracetamol (acetaminophen) sloution commercial
1 gm IV
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Baxter Healthcare Corporation ( Keyvan Tadjalli Mehr, MD ) |
Study ID Numbers: | R-01270-A015, EudraCT2005-005575-14 |
Study First Received: | November 29, 2006 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00406679 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
pain, postoperative surgery, oral surgery, dental |
Signs and Symptoms Postoperative Complications Toothache |
Pain Acetaminophen Pain, Postoperative |
Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |