A Comparison of Analgesic Efficacy Between a Single Dose of ORG 28611, Morphine, and Placebo After Dental Impaction Surgery (Study P05800)

NCT ID: NCT00782951

Last Updated: 2015-09-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2007-08-31

Brief Summary

Patients will receive a single intravenous (IV) infusion administered over 3 minutes of either ORG 28611 (SCH 900111), 0.12 mg/kg morphine sulphate, or placebo, within 6 hours after dental surgery, when they experience moderate to severe dental pain. Patient will then be evaluated with pain assessments at Baseline, 5, 10, 15, 30, 45, 60, and 90 minutes; and 2 through 8 hours or before rescue medication is needed.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Org 28611

Group Type: EXPERIMENTAL

Org 28611

Intervention Type: DRUG

single IV dose of Org 28611 3 mcg/kg after dental impaction surgery

morphine sulfate

Group Type: ACTIVE_COMPARATOR

morphine sulfate

Intervention Type: DRUG

single IV dose of morphine sulfate 0.12 mg/kg after dental impaction surgery

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single IV dose of placebo after dental impaction surgery

Interventions

Org 28611

single IV dose of Org 28611 3 mcg/kg after dental impaction surgery

Intervention Type: DRUG

morphine sulfate

single IV dose of morphine sulfate 0.12 mg/kg after dental impaction surgery

Intervention Type: DRUG

Placebo

single IV dose of placebo after dental impaction surgery

Intervention Type: DRUG

Other Intervention Names

SCH 900111

Eligibility Criteria

Inclusion Criteria

• Has at least one mandibular partial or full bony impacted third molar requiring extraction. An ipsilateral maxillary third molar may also be extracted as may any adjacent supernumerary tooth (teeth)
• Is willing and able to understand and complete the pain evaluations
• Is male aged 18 to 40 years (inclusive)
• A subject, who has sexual partners of child-bearing potential, has agreed to use barrier contraception in addition to having their partner use another method for three months from the time of dosing. Also has agreed to abstain from sexual intercourse with pregnant or lactating women or to use condoms.
• Has a body mass index (BMI) less than or equal to 32 kg/m^2 and has a body weight of at least 65 kg
• Is in generally good health
• Is able to speak, read, and understand English and provide meaningful written informed consent
• Is able to remain at the research center for the entire 24-hours trial period
• Has an initial pain intensity score of at least 45-mm on a 100-mm VAS and moderate or severe pain on a 4-point categorical scale within 6 hours of the end of surgery (VAS as the primary parameter and the categorical as a secondary parameter)
• Is willing to return to the research center for the post-treatment visit 5 to 9 days after surgery and complete a day 30 SAE telephone call.

Exclusion Criteria

• Has uncontrolled or clinically significant cardiovascular, respiratory, gastrointestinal, renal, hepatic, metabolic, hematological, or immunological disease
• Has a history of seizures, a family history of seizure disorder, or psychotic illness
• Has a known allergy or significant adverse reaction to opioids or opioid antagonists, paracetamol or ibuprofen
• Has a history of chronic opioid or cannabis use or abuse within 6 months prior to the start of this trial
• Has a positive urine drug test at screening or prior to surgery
• Has participated in a trial of an investigational drug or device within 30 days prior to the trial
• Has taken any of the following drugs within 4 hours or 5 elimination half-lives (whichever is greater) prior to dosing: aspirin, acetaminophen (paracetamol), nonsteroidal anti-inflammatory drugs (NSAIDs, COX-2 inhibitors), opioids, opioid combination drugs, sedative-hypnotics, muscle relaxants, and/or sedating antihistamines
• Has taken a long-acting analgesic (e.g., naproxen or celecoxib) or central nervous system (CNS) depressant within 12 hours prior to dosing
• Has taken a monoamine oxidase (MAO) inhibitor or tricyclic antidepressant drug within 4 weeks prior to administration of trial medication
• Has taken a selective serotonin or norepinephrine reuptake inhibitor (SSRI or SNRI) within 4 weeks prior to the start of the trial
• Has a medical or psychiatric condition which compromises the patient's ability to give informed consent or appropriately complete the pain assessments.
• Has an abnormal clinically significant EEG and/or an EEG indicating possible seizure(-like) disorder according to the following abnormalities (with or without clinical significance):

• spike and wave activity (epileptiform activity)
• paroxysmal activity
• abnormal slowing
• abnormal beta activity
• asymmetry right-left and anterior-posterior not within normal limits at screening
• Has had alcohol or caffeine in any form during 24 hours before the surgery
• Has abnormal laboratory results at the screening which in the opinion of the

investigator are exclusionary.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Study 231006;

Identifier Type: -

Identifier Source: secondary_id

EudraCT Number: 2006-002571-40

Identifier Type: -

Identifier Source: secondary_id

P05800

Identifier Type: -

Identifier Source: org_study_id