NCT01915979 is a Phase 3 clinical trial of Plasma rich in growth factors (PRGF) in Rotator Cuff Tendinopathy, sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias.

What drugs are being tested in NCT01915979?

Interventions in NCT01915979: Plasma rich in growth factors (PRGF), Celestone cronodose (Bethametasone).

What condition does NCT01915979 study?

NCT01915979 studies Rotator Cuff Tendinopathy.

Is NCT01915979 still recruiting?

NCT01915979 is currently completed. Last updated 18 December 2018.

Last reviewed 2018-12-18 · How we verify

NCT01915979

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Role of Biological Therapy in Rotator Cuff Tendinopathy. Effectiveness of Plasma Rich in Growth Factors Regarding Functional Capacity and Pain Compared With the Conventional Treatment Using Steroids

Completed Phase 3 Last updated 18 December 2018

What this trial tests

Phase 3 trial testing Plasma rich in growth factors (PRGF) in Rotator Cuff Tendinopathy in 84 participants. Completed in 31 December 2016.

Timeline

1 February 2014

Primary endpoint
1 May 2015

31 December 2016

Quick facts

Lead sponsor	Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	84
Start date	1 February 2014
Primary completion	1 May 2015
Estimated completion	31 December 2016
Sites	1 location across Spain

Drugs / interventions tested

Plasma rich in growth factors (PRGF) — full drug profile →
Celestone cronodose (Bethametasone) — full drug profile →

Conditions studied

Rotator Cuff Tendinopathy — all drugs for Rotator Cuff Tendinopathy →

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

Who can join

Adults 40 to 70, any sex, with Rotator Cuff Tendinopathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

15% of change in the score of the UCLA scale
Time frame: Baseline and 6 months
15% of change in the score of the QuickDash scale
Time frame: Baseline and 6 months

Sponsor's own description

The overall objective of the study is to assess the effectiveness of the treatment of degenerative rotator cuff tendinopathy using the application of plasma rich in growth factors (PRGF). Main objective: To show more effectiveness after 6 months of treatment with PRGF, with an improvement in the reference test of more than 15% compared to the treatment with corticosteroids. Secondary objective: * To assess the efficacy of the treatment after 12 months. * Quantification of platelet levels in patients treated with plasma rich in growth factors and its correlation with the clinical effect.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Rotator Cuff Tendinopathy

Currently open trials in the same condition.

NCT06809543 — Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy · NA · recruiting
NCT06517680 — Tight Control for Rotator Cuff Tendinopathy · NA · recruiting
NCT07164625 — Telerehabilitation vs. In-person Physiotherapy in Young Elite Baseball Players · NA · active not recruiting

Other Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias trials

Trials by the same sponsor.

NCT04164589 — EFFECTIVENESS OF THE NEUROADAPTATIVE FOR URGE INCONTINENCE · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01915979 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Last refreshed: 18 December 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01915979.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing