An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00240825 |
Recruitment Status :
Completed
First Posted : October 18, 2005
Last Update Posted : June 19, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Drug: Ibuprofen Drug: Placebo Drug: Acetaminophen | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 222 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain |
Actual Study Completion Date : | February 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: 001
Acetaminophen
|
Drug: Acetaminophen |
Experimental: 002
Ibuprofen
|
Drug: Ibuprofen |
Placebo Comparator: 003
Placebo
|
Drug: Placebo |
- Time at which the proportion of subjects indicating non-zero pain relief for each active treatment becomes statistically significantly superior to placebo.
- Pain intensity differences from baseline and pain relief at each measurement time; Area under the curve of pain relief scores at 1 hour (TOTPAR1); Pain intensity differences at 1 hour (SPID1); Subject's global assessment of pain relief at one hour

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Indicates moderate to severe pain following the extraction of at least three molars (including at least one partial or complete bony mandibular third molar impaction)
- weighs at least 100 pounds and has a Body Mass Index (BMI) between 18 and 28
- Not taking any medications for anxiety, depression or schizophrenia
- if female, not pregnant or breastfeeding
Exclusion Criteria:
- Used ibuprofen or acetaminophen Used ibuprofen or acetaminophen within 12 hours preceding surgery or any other pain relievers or anti-inflammatory drugs within 24 hours preceding surgery
- have any gastrointestinal disease that would interfere with the absorption and excretion of study medications
- unable to swallow the study medication whole
- have any significant medical condition
- have a history of adverse reactions to acetaminophen, ibuprofen or any anesthetic agent used in the extraction

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240825
Study Director: | McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
Responsible Party: | Johnson & Johnson Consumer and Personal Products Worldwide |
ClinicalTrials.gov Identifier: | NCT00240825 |
Other Study ID Numbers: |
CR002812 |
First Posted: | October 18, 2005 Key Record Dates |
Last Update Posted: | June 19, 2015 |
Last Verified: | June 2015 |
postoperative dental pain acetaminophen ibuprofen |
Toothache Tooth Diseases Stomatognathic Diseases Facial Pain Pain Neurologic Manifestations Acetaminophen Ibuprofen Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |