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

NCT00782951 | Terminated Phase 2

• 3 other identifiers: P05800Study 231006;EudraCT Number: 2006-002571-40
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Total Pain Relief Score (TOTPAR)

  from 0 to 4 hours

Secondary Outcomes (5)

• Pain Intensity (PI) on a visual analog scale (VAS), PI difference in VAS from Baseline, PI difference on a categorical scale, PI difference on categorical scale from Baseline, Pain Relief (PR) on a categorical scale, PR Intensity Difference (PRID).

  at Baseline, 5, 10, 15, 30, 45, 60, and 90 minutes; and 2 through 8 hours or before rescue medication

• Time to rescue medication, time to perceptual and meaningful pain relief (stopwatch), time to onset of analgesia, Peak Pain Intensity Difference (PPID), Peak Pain Relief (PPR).

  After surgery

• Global evaluation of trial medication on a 5-point categorical scale at 8 hours or just prior to rescue medication

  at 8 hours or just prior to rescue medication

• TOTPAR

  over 2, 6, and 8-hour intervals

• Summed pain intensity difference (SPID) calculated using PID categorical scale and PID VAS scale, Summed pain relief intensity difference (SPRID),

  Over 2, 4, 6, and 8-hour intervals

Study Arms (3)

Org 28611

EXPERIMENTAL

Drug: Org 28611

morphine sulfate

ACTIVE COMPARATOR

Drug: morphine sulfate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Org 28611 DRUG

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

Also known as: SCH 900111

Org 28611

morphine sulfate DRUG

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

morphine sulfate

Placebo DRUG

single IV dose of placebo after dental impaction surgery

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Agnosia

Interventions

Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: July 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: September 14, 2015

Record last verified: 2015-09