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

NCT00743587 | Completed Phase 1

• 1 other identifier: A9001383
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. These agents are: tramadol, naproxen and oxycodone.

Conditions

Osteoarthritis Thumbs

Outcome Measures

Primary Outcomes (1)

• Pressure pain threshold - area under the curve

  0 to 4 hours

Secondary Outcomes (2)

• Pressure pain threshold - at specific time points

  0 to 12 hours

• Present pain intensities - at specific time points

  0 to 12 hours

Study Arms (4)

A

PLACEBO COMPARATOR

Drug: Placebo

B

ACTIVE COMPARATOR

Drug: Oxycodone

C

ACTIVE COMPARATOR

Drug: Tramadol

D

ACTIVE COMPARATOR

Drug: Naproxen

Interventions

Placebo DRUG

Oral, a double-dummy approach will be used to maintain the blind between active tablet and capsule doses

A

Oxycodone DRUG

Oral, 1 x 20mg controlled-release tablets

Also known as: Oxycontin

B

Tramadol DRUG

Oral, 2 x 50mg immediate release capsules

Also known as: Dolzam

C

Naproxen DRUG

Oral, 1 x 500mg enteric-coated

Also known as: Naprosyne

D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Oxycodone; Tramadol; Naproxen

Intervention Hierarchy (Ancestors)

Codeine; 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; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Naphthaleneacetic Acids; Naphthalenes; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

BE (1)