Phase 2 Study of Indomethacin Capsules to Treat Dental Pain - Full Text View

Sponsor:	Iroko Pharmaceuticals, LLC
Information provided by:	Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00964431

Purpose

The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.

Condition	Intervention	Phase
Analgesia	Drug: Celecoxib Drug: Placebo Drug: Indomethacin Test (lower dose) Drug: Indomethacin Test (upper dose)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Indomethacin Test Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars

Resource links provided by NLM:

Drug Information available for: Indomethacin Celecoxib

U.S. FDA Resources

Further study details as provided by Iroko Pharmaceuticals, LLC:

Primary Outcome Measures:

TOTPAR [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	August 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Indomethacin Test (lower dose): Experimental	Drug: Indomethacin Test (lower dose) Single dose
Indomethacin Test (upper dose): Experimental Single dose	Drug: Indomethacin Test (upper dose) Single dose
Celecoxib: Active Comparator	Drug: Celecoxib Capsules 2 x 200 mg Single-Dose
Placebo: Placebo Comparator	Drug: Placebo Capsules 2 Single-Dose

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is male or female between 18 and 50 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Patient requires extraction of 2 or more third molars
Patient must be willing to stay at the study site for at least 8 hours after dosing of the study drug

Exclusion Criteria:

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to Screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964431

Locations

United States, Texas
Premier Research Group Limited
Austin, Texas, United States, 78705

Sponsors and Collaborators

Iroko Pharmaceuticals, LLC

More Information

No publications provided

Responsible Party:	Iroko Pharmaceuticals, LLC ( George Van Lear, Ph.D., Executive Director, Development )
Study ID Numbers:	IND2-08-03
Study First Received:	August 24, 2009
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00964431 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Reproductive Control Agents
Gout Suppressants
Pharmacologic Actions

Tocolytic Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010