Acute PainPhase 2NCT00993863
Analgesic Efficacy and Safety of ADL5859 in Subjects With Acute Dental Pain After Third Molar Extraction
A Phase 2 study testing ADL5859 30 mg, ADL5859 100 mg and ADL5859 200 mg in people with Acute Pain, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- ADL5859 30 mg, ADL5859 100 mg and ADL5859 200 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Sep 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Acute Pain
- Being tested
- Placebo, ADL5859 30 mg, ADL5859 100 mg, ADL5859 200 mg, ibuprofen 400 mg
- Keywords
- delta opioid agonist, dental pain
- Medical subject headings
- Acute Pain, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
single dose
ADL5859 30 mgDrug
single dose
ADL5859 100 mgDrug
single dose
ADL5859 200 mgDrug
single dose
ibuprofen 400 mgDrug
Also called Advil
single dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| ADL5859 30 mg | Experimental | Not described Receives: Drug: ADL5859 30 mg |
| ADL5859 100 mg | Experimental | Not described Receives: Drug: ADL5859 100 mg |
| ADL5859 200 mg | Experimental | Not described Receives: Drug: ADL5859 200 mg |
| ibuprofen 400 mg | Active comparator | Not described Receives: Drug: ibuprofen 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pain relief 0-4 hours after study medication
Measured: 4 hours after study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startJun 2007
- Primary completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- 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
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993863
- Sponsor's protocol ID
- 33CL230
- Other IDs
- 33CL230
- Status last verified
- Oct 2009
- First submitted
- 9 Oct 2009
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00993863
- Acronym / sponsor ID
- 33CL230
- Conditions
- Acute Pain
- Keywords
- delta opioid agonist, dental pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Sep 2007 (actual)
- First posted
- 14 Oct 2009 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| ADL5859 30 mg | Experimental | Drug: ADL5859 30 mg |
| ADL5859 100 mg | Experimental | Drug: ADL5859 100 mg |
| ADL5859 200 mg | Experimental | Drug: ADL5859 200 mg |
| ibuprofen 400 mg | Active comparator | Drug: ibuprofen 400 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 (7 listed)
- 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
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 |
|---|---|---|
| Placebosingle dose | Drug | Placebo |
| ADL5859 30 mgsingle dose | Drug | ADL5859 30 mg |
| ADL5859 100 mgsingle dose | Drug | ADL5859 100 mg |
| ADL5859 200 mgsingle dose | Drug | ADL5859 200 mg |
| ibuprofen 400 mgAlso: Advilsingle dose | Drug | ibuprofen 400 mg |
Primary outcome
Total pain relief 0-4 hours after study medication
Time frame: 4 hours after study medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADL5859 30 mg, ADL5859 100 mg and ADL5859 200 mg in people with Acute Pain, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 0-4 hours after study medication (time frame: 4 hours after study medication). 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 17 Jul 2015.