Analgesic Efficacy and Safety of ADL5859 in Subjects With Acute Dental Pain After Third Molar Extraction

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00993863
First received: October 9, 2009
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

The objective of this study is to evaluate the analgesic efficacy and safety of ADL5859 compared with placebo and an active control (ibuprofen) in subjects with acute dental pain after third molar extraction.


Condition Intervention Phase
Acute Pain
Drug: Placebo
Drug: ADL5859 30 mg
Drug: ADL5859 100 mg
Drug: ADL5859 200 mg
Drug: ibuprofen 400 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Dose, Double-Blind, Active- and Placebo-Controlled Study of ADL5859 for the Treatment of Pain After Surgical Removal of Impacted Third Molars

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Total pain relief 0-4 hours after study medication [ Time Frame: 4 hours after study medication ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: June 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
single dose
Experimental: ADL5859 30 mg Drug: ADL5859 30 mg
single dose
Experimental: ADL5859 100 mg Drug: ADL5859 100 mg
single dose
Experimental: ADL5859 200 mg Drug: ADL5859 200 mg
single dose
Active Comparator: ibuprofen 400 mg Drug: ibuprofen 400 mg
single dose
Other Name: Advil

  Eligibility

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

Key Inclusion Criteria:

  • have 2 or more 3rd molars requiring extraction, including at least 1 partially or completely bone-impacted mandibular molar
  • experience moderate to severe pain intensity as measured by the Numeric Pain Rating Scale (NPRS) (score ≥ 5) within 6 hours after surgery
  • for male subjects, be surgically sterile or agree to use an appropriate method of contraception or have a sexual partner who is surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive
  • for female subjects, be using contraceptives, be postmenopausal, or have undergone hysterectomy or tubal ligation
  • be able to take oral study medications

Key Exclusion Criteria:

  • have positive results either on the urine screening tests for opiates, tetrahydrocannabinol,cocaine, amphetamines, barbiturates, benzodiazepines, phencyclidine, or propoxyphene or on the alcohol breathalyzer test
  • have a history of alcoholism or drug addiction or abuse within 5 years before dosing with study medication
  • have a history of chronic use (defined as daily use for > 2 weeks) of glucocorticoids,nonsteroidal anti-inflammatory drugs, or opiates for any condition within 6 months of study medication administration
  • have a known allergy or history of significant reaction to any of the known treatment medications (ADL5859-like compounds or ibuprofen) or rescue pain medication (acetaminophen)
  • have significant renal or hepatic disease, as indicated by clinical laboratory assessment
  • have a known history of epilepsy or seizure disorder, including history of febrile seizure, or any other medical or psychiatric condition that, in the judgment of the investigator, would put the subject at risk while in the study, could influence the results of the study, or could negatively affect the subject's ability to participate in the study
  • have a history or evidence of orthostatic hypotension at screening have a history of significant head trauma (head injury with loss of consciousness)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993863

Locations
United States, Texas
SCIREX Research Center
Austin, Texas, United States, 78705
Sponsors and Collaborators
Cubist Pharmaceuticals
  More Information

No publications provided

Responsible Party: Senior Medical Director, Clinical Research, Adolor Corporation
ClinicalTrials.gov Identifier: NCT00993863     History of Changes
Other Study ID Numbers: 33CL230, 33CL230
Study First Received: October 9, 2009
Last Updated: October 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
delta opioid agonist
dental pain

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014