Evidence map›Paper›PMID 34350546›Full record

Trial reportDrugs in R&D2021

Safety and Systemic Exposure of Triamcinolone Acetonide Following Ultrasound-Guided Intra-Articular Injection of Triamcinolone Extended-Release or Standard Triamcinolone Acetonide in Patients with Shoulder Osteoarthritis: An Open-Label, Randomized Study.

Peter Hanson, Alan Kivitz, Purvi Mehra, Louis Kwong, Amy Cinar, Joelle Lufkin, Scott D Kelley

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drugs in R&D, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03382262 (A Randomized, Open-label Study Comparing the Systemic Exposure to Triamcinolone Acetonide Following a Single Intra-articular Dose of Extended-release FX006 or Immediate-release TAcs), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03382262 phase2completednot on this map

A Randomized, Open-label Study Comparing the Systemic Exposure to Triamcinolone Acetonide Following a Single Intra-articular Dose of Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension) in Patients With Osteoarthritis of the Shoulder (Glenohumeral Joint) or Hip

TypeinterventionalSponsorPacira Pharmaceuticals, IncRan2017 to 2018Enrolled55ConditionsOsteoarthritis of the Shoulder, Osteoarthritis of the HipArmsFX006 32 mg, TAcs 40 mg
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. The Challenges of Local Intra-Articular Therapy.Medicina (Kaunas, Lithuania) · 2024
    Review
  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Peter HansonBioSolutions Clinical Research Center, La Mesa, CA, USA.
Alan KivitzAltoona Center for Clinical Research, Duncansville, PA, USA.
Purvi MehraARTEMIS Institute for Clinical Research, San Diego, CA, USA.
Louis KwongHarbor-UCLA Medical Center, Torrance, CA, USA.
Amy CinarFlexion Therapeutics, Inc., Burlington, MA, 01803, USA.
Joelle LufkinFlexion Therapeutics, Inc., Burlington, MA, 01803, USA.
Scott D KelleyFlexion Therapeutics, Inc., Burlington, MA, 01803, USA. sdkelley@bwh.harvard.edu.
Flexion Therapeutics (United States) · USAltoona Center for Clinical Research · USArtemis (United States) · USTherapeutics Clinical Research · USUCLA Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesOsteoarthritis (OA) is a major public health burden. While knee and hip joints are most commonly affected, the glenohumoral (shoulder) joint is also frequently involved. We evaluated the pharmacokinetics and safety/tolerability of triamcinolone acetonide extended-release (TA-ER) and triamcinolone acetonide crystalline suspension (TAcs) in patients with shoulder OA.

methodsIn this phase 2, randomized, open-label, single-dose study (NCT03382262), adults with moderately-to-severely symptomatic shoulder OA for ≥ 6 months randomly received a single ultrasound-guided intra-articular (IA) injection of TA-ER 32 mg or TAcs 40 mg. Safety was evaluated throughout 12 weeks post-injection; blood samples for pharmacokinetic evaluations were collected pre-injection and through Day 85 post-injection.

resultsAmong 25 randomized patients, 12 received TA-ER and 13 received TAcs. Most patients were female (60%), and all had moderate (72%) or severe (28%) shoulder OA. Adverse events (AEs) were reported by four (33%) patients following TA-ER and three (23%) following TAcs injection. No AE was serious or led to study discontinuation. Systemic exposure following TAcs was approximately 1.5-fold higher than that following TA-ER injection (geometric mean [GM] AUC

conclusionThese pharmacokinetic data confirm protracted release of TA from TA-ER following IA injection in patients with shoulder OA. Lower peak and systemic TA exposure following TA-ER suggests TA-ER could potentially confer an improved systemic safety profile over TAcs. TRIAL REGISTRATION NUMBER: NCT03382262 (December 22, 2017 retrospectively registered).

Indexed as

Osteoarthritis, KneeTriamcinolone AcetonideAdultDelayed-Action PreparationsFemaleHumansInjections, Intra-ArticularShoulderTreatment OutcomeUltrasonography, InterventionalDelayed-Action PreparationsTriamcinolone Acetonide

Identifiers

PMID34350546
PMCPMC8363704
OpenAlexW3190578895

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.