Trial intelligence / Profile preview

Methylprednisolone vs Triamcinolone in Shoulder Calcific Tendinopathy

NCT01652495Phase 4

Key facts

Status
Completed
Start
Mar 2012
Primary completion
May 2013
Countries
1
Sponsor
Istituto Ortopedico Rizzoli
Modality
Orthosteric Ligands
Conditions
Calcific tendinitis of the rotator cuff
01

Overview

Phase 4, randomised trial in Calcific tendinitis of the rotator cuff comparing Methylprednisolone acetate with Triamcinolone acetonide (2 arms). Primary endpoint: Functional Improvement Measured According to Percentage Change in Constant Score at 180 days. Started Mar 2012; status: completed.

02

Design

2 arms
Study design
Randomized
  • Methylprednisolone acetate

    Single injection of 40 mg methylprednisolone acetate

  • Triamcinolone acetonide

    Single injection of 40 mg triamcinolone acetonide

03

Who it enrols

Patients with painful rotator cuff calcific tendonitis. Excludes patients with diabetes, glaucoma, coagulopathies, systemic chronic inflammatory diseases, or recent corticosteroid use.

04

Endpoints

Primary

  • Functional Improvement Measured According to Percentage Change in Constant Score

Secondary

  • Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis

  • Reduction of Pain Severity Expressed as Percentage Change in VAS Score

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