You are here

A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis Thumbs
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

- 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.

NCT00743587
Pfizer
Completed
A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Hip Osteoarthritis, Knee Osteoarthritis
NCT02709486
All Genders
18+
Years
Multiple Sites
Chronic Pain, Hip Osteoarthritis, Knee Osteoarthritis
NCT02528188
All Genders
18+
Years
Multiple Sites
A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Osteoarthritis Thumbs
  • Drug: Placebo
    Oral, a double-dummy approach will be used to maintain the blind between active tablet and capsule doses
  • Drug: Oxycodone
    Oral, 1 x 20mg controlled-release tablets
    Other Name: Oxycontin
  • Drug: Tramadol
    Oral, 2 x 50mg immediate release capsules
    Other Name: Dolzam
  • Drug: Naproxen
    Oral, 1 x 500mg enteric-coated
    Other Name: Naprosyne
  • Placebo Comparator: A
    Intervention: Drug: Placebo
  • Active Comparator: B
    Intervention: Drug: Oxycodone
  • Active Comparator: C
    Intervention: Drug: Tramadol
  • Active Comparator: D
    Intervention: Drug: Naproxen
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00743587
A9001383
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now