AnalgesiaPhase 2NCT00782951
A Comparison of Analgesic Efficacy Between a Single Dose of ORG 28611, Morphine, and Placebo After Dental Impaction Surgery (Study P05800)
A Phase 2 study testing Org 28611 and morphine sulfate in people with Analgesia, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Org 28611 and morphine sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
About this study
Official title: A Randomized, Double-blind, Active and Placebo Controlled Trial to Compare the Relative Analgesic Efficacy and Safety of a Single Intravenous Dose of ORG 28611 3 mcg/kg, Morphine Sulfate 0.12 mg/kg, and Placebo in Patients Experiencing Moderate to Severe Pain After Dental Impaction Surgery.
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
- Being tested
- Org 28611, morphine sulfate, Placebo
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Org 28611Drug
Also called SCH 900111
single IV dose of Org 28611 3 mcg/kg after dental impaction surgery
morphine sulfateDrug
single IV dose of morphine sulfate 0.12 mg/kg after dental impaction surgery
PlaceboDrug
single IV dose of placebo after dental impaction surgery
| Study group | Role | What they receive |
|---|---|---|
| Org 28611 | Experimental | Not described Receives: Drug: Org 28611 |
| morphine sulfate | Active comparator | Not described Receives: Drug: morphine sulfate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pain Relief Score (TOTPAR)
Measured: 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).
Measured: 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).
Measured: After surgery
Global evaluation of trial medication on a 5-point categorical scale at 8 hours or just prior to rescue medication
Measured: at 8 hours or just prior to rescue medication
TOTPAR
Measured: 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),
Measured: Over 2, 4, 6, and 8-hour intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJul 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782951
- Sponsor's protocol ID
- P05800
- Other IDs
- Study 231006;, EudraCT Number: 2006-002571-40
- Status last verified
- Sep 2015
- First submitted
- 30 Oct 2008
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active and Placebo Controlled Trial to Compare the Relative Analgesic Efficacy and Safety of a Single Intravenous Dose of ORG 28611 3 mcg/kg, Morphine Sulfate 0.12 mg/kg, and Placebo in Patients Experiencing Moderate to Severe Pain After Dental Impaction Surgery.
- ClinicalTrials.gov ID
- NCT00782951
- Acronym / sponsor ID
- P05800
- Conditions
- Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Org 28611 | Experimental | Drug: Org 28611 |
| morphine sulfate | Active comparator | Drug: morphine sulfate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Org 28611Also: SCH 900111single IV dose of Org 28611 3 mcg/kg after dental impaction surgery | Drug | Org 28611 |
| morphine sulfatesingle IV dose of morphine sulfate 0.12 mg/kg after dental impaction surgery | Drug | morphine sulfate |
| Placebosingle IV dose of placebo after dental impaction surgery | Drug | Placebo |
Primary outcome
Total Pain Relief Score (TOTPAR)
Time frame: from 0 to 4 hours
5 secondary outcomes
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).
Time frame: 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).
Time frame: After surgery
Global evaluation of trial medication on a 5-point categorical scale at 8 hours or just prior to rescue medication
Time frame: at 8 hours or just prior to rescue medication
TOTPAR
Time frame: 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),
Time frame: Over 2, 4, 6, and 8-hour intervals
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Org 28611 and morphine sulfate in people with Analgesia, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pain Relief Score (TOTPAR) (time frame: from 0 to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2015.