NCT00981357

Brief Summary

Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme in animals and healthy human volunteers. The purpose of this study is to evaluate whether PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and whether this results in these patients experiencing less pain.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

September 21, 2009

Last Update Submit

September 13, 2017

Conditions

Osteoarthritis, Knee

Keywords

Cross-over evaluate the efficacy of PF-04457845 in relieving pain due to osteoarthritis OA knee osteoarthritis of knee pain due to osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • To evaluate the efficacy of PF-04457845 (administered QD) versus placebo in relieving pain as measured by the WOMAC Pain sub-score in patients with osteoarthritis of the knee

    8 weeks

  • To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis.

    10 weeks

Secondary Outcomes (9)

  • Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Stiffness domain score (Likert scale for 2 items, overall score ranges from 0-8) in patients with osteoarthritis of the knee.

    8 weeks

  • Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Physical Function domain score (Likert scale for 17 items, overall score ranges from 0-68) in patients with osteoarthritis of the knee.

    8 weeks

  • Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee.

    8 weeks

  • Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Importance weighted Total WOMAC score in patients with osteoarthritis of the knee.

    8 weeks

  • Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Daily pain diary over weeks 1 and 2 of each treatment period using an 11-point Numeric Rating Scale (NRS) in patients with osteoarthritis of the knee.

    8 weeks

  • +4 more secondary outcomes

Study Arms (4)

PF-04457845 followed by placebo

EXPERIMENTAL
Drug: PF-04457845

Placebo followed by PF-04457845

EXPERIMENTAL
Drug: PF-04457845

Naproxen followed by placebo

ACTIVE COMPARATOR
Drug: Naproxen

Placebo followed by Naproxen

ACTIVE COMPARATOR
Drug: Naproxen

Interventions

PF-04457845DRUG

PF-04457845 4 mg tablet once daily / matched placebo

PF-04457845 followed by placebo
NaproxenDRUG

Naproxen 500 mg tablet twice daily / matched placebo

Naproxen followed by placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray
  • Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study)
  • Subjects can be male or female between the ages of 18 and 75 years inclusive, but female subjects must not be able become pregnant

You may not qualify if:

  • Subjects must not have any condition or medical history that might interfere with their ability to complete the study assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Arthritis & Rheumatic Care Center

Miami, Florida, 33143, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66211, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

CEDRA Clinical Research, LLC

San Antonio, Texas, 78217, United States

Location

Diex Research Inc.

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Centrum for klinisk provning

Gothenburg, 405 30, Sweden

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

N-pyridazin-3-yl-4-(3-((5-(trifluoromethyl)pyridin-2-yl)oxy)benzylidene)piperidine-1-carboxamideNaproxen

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

November 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

CA(1)SE(1)US(5)