Osteoarthritis ThumbsPhase 1NCT00743587
A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb
A Phase 1 study testing Oxycodone, Tramadol and Naproxen in people with Osteoarthritis Thumbs, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to determine if the measurement of pressure pain thresholds, in patients suffering osteoarthritis of the thumb, can be used to assess the activity of potential analgesic agents after a single dose. The study will use agents known to give pain relief in osteoarthritis as positive controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Thumbs
- What is being tested?
- Oxycodone, Tramadol and Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2008to Mar 2009
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The clinical diagnosis of osteoarthritis of the hand, of at least 6 months duration.
- Pain around one of the thumb joints due to osteoarthritis. The patient must report the average pain in this joint, in the week prior to screening, as at least 5 on an 11-point numerical pain rating scale at the time of screening.
- The patient must demonstrate pressure pain at a thumb joint by reporting a pressure pain threshold lower than 300 kPa.
Who cannot join
- Pregnant (as judged by a urine pregnancy test) or lactating female.
- Other severe pain which may impair the assessment of the pain due to osteoarthritis.
- Skin condition over the thumb joint, which will be used for pain threshold testing, that could interfere with the assessment of pain thresholds.
- Known hypersensitivity to oxycodone, NSAIDS or tramadol.
- Patients in whom NSAIDS, oxycodone or tramadol are contraindicated, or patients taking any concurrent medications which are contraindicated with any of the study medications .
- An estimated renal clearance of less than 30 mL/min based on the Cockcroft Gault equation.
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- Use of prohibited medications as listed below, in the absence of appropriate washout periods:
- Oral or intramuscular corticosteroids within 4 weeks prior to screening.
- Monoamine oxidase inhibitors within 2 weeks of screening.
- Analgesic agents, other than aspirin, or acetaminophen within 1 week prior to screening. (Aspirin use less than or equal to 325 mg per day for cardiovascular prophylaxis is permitted)
- Acetaminophen up to 4 g/day may be used, provided it is not used in the 24 hours prior to any assessment of pain thresholds.
- Intra-articular steroid injections into the study joint within 12 weeks, or to any other joint within 4 weeks, prior to screening.
- History of chronic constipation, or of any condition which, in the opinion of the investigator, may put the patient at increased risk of respiratory depression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo And Active Controlled Methodology Study Investigating The Effects Of Tramadol And Naproxen On The Pain Thresholds Of Patients With Severe Pain Due To Osteoarthritis Of The Thumb
The purpose of this study is to determine if the measurement of pressure pain thresholds, in patients suffering osteoarthritis of the thumb, can be used to assess the activity of potential analgesic agents after a single dose. The study will use agents known to give pain relief in osteoarthritis as positive controls. These agents are: tramadol, naproxen and oxycodone.
- Conditions
- Osteoarthritis Thumbs
- Being tested
- Placebo, Oxycodone, Tramadol, Naproxen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral, a double-dummy approach will be used to maintain the blind between active tablet and capsule doses
OxycodoneDrug
Also called Oxycontin
Oral, 1 x 20mg controlled-release tablets
TramadolDrug
Also called Dolzam
Oral, 2 x 50mg immediate release capsules
NaproxenDrug
Also called Naprosyne
Oral, 1 x 500mg enteric-coated
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Placebo |
| B | Active comparator | Not described Receives: Drug: Oxycodone |
| C | Active comparator | Not described Receives: Drug: Tramadol |
| D | Active comparator | Not described Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold - area under the curve
Measured: 0 to 4 hours
Secondary outcomes (2)
Pressure pain threshold - at specific time points
Measured: 0 to 12 hours
Present pain intensities - at specific time points
Measured: 0 to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ThumbsStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743587
- Sponsor's protocol ID
- A9001383
- Status last verified
- Nov 2018
- First submitted
- 28 Aug 2008
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo And Active Controlled Methodology Study Investigating The Effects Of Tramadol And Naproxen On The Pain Thresholds Of Patients With Severe Pain Due To Osteoarthritis Of The Thumb
- ClinicalTrials.gov ID
- NCT00743587
- Acronym / sponsor ID
- A9001383
- Conditions
- Osteoarthritis Thumbs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 29 Aug 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.
The purpose of this study is to determine if the measurement of pressure pain thresholds, in patients suffering osteoarthritis of the thumb, can be used to assess the activity of potential analgesic agents after a single dose. The study will use agents known to give pain relief in osteoarthritis as positive controls. These agents are: tramadol, naproxen and oxycodone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Placebo |
| B | Active comparator | Drug: Oxycodone |
| C | Active comparator | Drug: Tramadol |
| D | Active comparator | Drug: Naproxen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The clinical diagnosis of osteoarthritis of the hand, of at least 6 months duration.
- Pain around one of the thumb joints due to osteoarthritis. The patient must report the average pain in this joint, in the week prior to screening, as at least 5 on an 11-point numerical pain rating scale at the time of screening.
- The patient must demonstrate pressure pain at a thumb joint by reporting a pressure pain threshold lower than 300 kPa.
Key exclusion criteria (13 listed)
- Pregnant (as judged by a urine pregnancy test) or lactating female.
- Other severe pain which may impair the assessment of the pain due to osteoarthritis.
- Skin condition over the thumb joint, which will be used for pain threshold testing, that could interfere with the assessment of pain thresholds.
- Known hypersensitivity to oxycodone, NSAIDS or tramadol.
- Patients in whom NSAIDS, oxycodone or tramadol are contraindicated, or patients taking any concurrent medications which are contraindicated with any of the study medications .
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 |
|---|---|---|
| PlaceboOral, a double-dummy approach will be used to maintain the blind between active tablet and capsule doses | Drug | A |
| OxycodoneAlso: OxycontinOral, 1 x 20mg controlled-release tablets | Drug | B |
| TramadolAlso: DolzamOral, 2 x 50mg immediate release capsules | Drug | C |
| NaproxenAlso: NaprosyneOral, 1 x 500mg enteric-coated | Drug | D |
Primary outcome
Pressure pain threshold - area under the curve
Time frame: 0 to 4 hours
2 secondary outcomes
Pressure pain threshold - at specific time points
Time frame: 0 to 12 hours
Present pain intensities - at specific time points
Time frame: 0 to 12 hours
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 4 Dec 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Osteoarthritis Thumbs
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Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
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Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
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Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxycodone, Tramadol and Naproxen in people with Osteoarthritis Thumbs, run by Pfizer at 1 site in Belgium.
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 3 inclusion and 13 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 4 Dec 2018. 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 Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pressure pain threshold - area under the curve (time frame: 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 4 Dec 2018.