OASIS: Osteoarthritis Sensitivity Integration Study

NCT ID: NCT01377038

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-07-31

Brief Summary

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The primary objective of this study is to evaluate the relative efficacy of a centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical diclofenac) for pain and associated symptom management in knee osteoarthritis. Secondary objectives include the determination of which self-report and experimental pain measures best differentiate those who respond better to duloxetine than diclofenac.

Detailed Description

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This is a randomized, blinded, crossover, controlled study design comparing duloxetine and topical diclofenac for osteoarthritis pain.

The study cohort will be individuals who have a confirmed diagnosis of knee osteoarthritis. Subjects will be randomized only after all entry criteria have been met. These individuals will be evaluated at baseline, and then followed longitudinally following enrollment.

Conditions

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Osteoarthritis Chronic Pain

Keywords

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Osteoarthritis Chronic pain Central pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Duloxetine

Phenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks.

Group Type ACTIVE_COMPARATOR

Phenotype assessment

Intervention Type OTHER

Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype

Diclofenac

Phenotype assessment prior to and after treatment with topical diclofenac four times daily

Group Type ACTIVE_COMPARATOR

Phenotype assessment

Intervention Type OTHER

Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype

Interventions

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Phenotype assessment

Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with knee osteoarthritis as defined by American College of Rheumatology (ACR) criteria
* Males and females age greater than 50 years at time of screening

Exclusion Criteria

* History of chronic kidney disease or moderate to severe hepatic impairment
* History of anemia
* Allergy or intolerance of drug intervention
* Inability to participate in outcome measures
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Kristine Phillips

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristine Phillips, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Murphy SL, Lyden AK, Kratz AL, Fritz H, Williams DA, Clauw DJ, Gammaitoni AR, Phillips K. Characterizing Pain Flares From the Perspective of Individuals With Symptomatic Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2015 Aug;67(8):1103-11. doi: 10.1002/acr.22545.

Reference Type DERIVED
PMID: 25580697 (View on PubMed)

Other Identifiers

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2011 HUM00044644

Identifier Type: -

Identifier Source: org_study_id