Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica

NCT ID: NCT00982332

Last Updated: 2010-07-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.

Detailed Description

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Conditions

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Polymyalgia Rheumatica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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betamethasone

patients treated with a single intramuscular injection of betamethasone

Group Type ACTIVE_COMPARATOR

Betamethasone

Intervention Type DRUG

betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection

isotonic sodium chloride solution (placebo)

Intervention Type DRUG

4 ml intramuscular

isotonic sodium chloride solution

Group Type PLACEBO_COMPARATOR

isotonic sodium chloride solution (placebo)

Intervention Type DRUG

4 ml intramuscular

Interventions

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Betamethasone

betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection

Intervention Type DRUG

isotonic sodium chloride solution (placebo)

4 ml intramuscular

Intervention Type DRUG

Other Intervention Names

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diprospan injection

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of polymyalgia rheumatica

Exclusion Criteria

* decompensated diabetes mellitus
* decompensated arterial hypertension
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bnai Zion MC

Locations

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Bnai Zion Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Gleb Slobodin, MD

Role: CONTACT

972-506267284

Facility Contacts

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Gleb Slobodin, MD

Role: primary

972-506267284

Other Identifiers

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POLYMYALGIA1

Identifier Type: -

Identifier Source: org_study_id

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