- |||||||||| Zilretta (triamcinolone acetonide ER) / Pacira
Enrollment open, Trial completion date, Trial primary completion date: Effect of Zilretta Injection (clinicaltrials.gov) - Sep 22, 2020 P1, N=35, Recruiting, Trial completion date: Jun 2020 --> Mar 2021 | Trial primary completion date: Jun 2020 --> Mar 2021 Not yet recruiting --> Recruiting | Trial completion date: Feb 2022 --> Sep 2023 | Trial primary completion date: Feb 2022 --> Sep 2023
- |||||||||| Zilretta (triamcinolone acetonide ER) / Pacira
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis (clinicaltrials.gov) - Jun 29, 2020 P2, N=19, Terminated, Suspended --> Recruiting N=250 --> 19 | Trial completion date: Feb 2021 --> Jun 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2020 --> Jun 2020; The study was terminated prematurely due to the COVID-19 pandemic creating uncertainty impacting trial progress and costs.
- |||||||||| Zilretta (triamcinolone acetonide ER) / Pacira
Trial completion: Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee (clinicaltrials.gov) - May 27, 2020 P3, N=129, Completed, N=250 --> 19 | Trial completion date: Feb 2021 --> Jun 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2020 --> Jun 2020; The study was terminated prematurely due to the COVID-19 pandemic creating uncertainty impacting trial progress and costs. Active, not recruiting --> Completed
- |||||||||| triamcinolone acetonide / Generic mfg., Zilretta (triamcinolone acetonide ER) / Flexion Therap
Clinical, Retrospective data, Journal: Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis. (Pubmed Central) - May 19, 2020 P3 TA-ER provided 5-6 months' pain relief that consistently exceeded saline-placebo and TAcs, suggesting that TA-ER injected intra-articularly into the affected knee may be an effective non-opioid treatment option. Although the participants included in this analysis did not fully represent the diverse demographics of active service members, the substantial unmet medical need in the military population suggests that TA-ER may be an important treatment option; additional studies of TA-ER in active military patients are needed.
- |||||||||| triamcinolone acetonide / Generic mfg., Zilretta (triamcinolone acetonide ER) / Flexion Therap, Decadron (dexamethasone) / Merck (MSD)
Journal: Sustained-Release Triamcinolone Acetonide Hydrogels Reduce Hearing Threshold Shifts in a Model for Cochlear Implantation with Hearing Preservation. (Pubmed Central) - May 19, 2020 Although the participants included in this analysis did not fully represent the diverse demographics of active service members, the substantial unmet medical need in the military population suggests that TA-ER may be an important treatment option; additional studies of TA-ER in active military patients are needed. In summary, we were able to demonstrate functional benefits of a single preoperative application of a TAAC hydrogel in a guinea pig model for CI, which persisted until the end of the observational period, that is, 28 days after surgery.
- |||||||||| ibuprofen / Generic mfg.
Journal: Drugs for osteoarthritis. (Pubmed Central) - May 13, 2020 In summary, we were able to demonstrate functional benefits of a single preoperative application of a TAAC hydrogel in a guinea pig model for CI, which persisted until the end of the observational period, that is, 28 days after surgery. No abstract available
- |||||||||| Zilretta (triamcinolone acetonide ER) / Pacira
Trial initiation date: Effect of Zilretta Injection (clinicaltrials.gov) - Mar 24, 2020 P1, N=35, Not yet recruiting, Recruiting --> Active, not recruiting Initiation date: Mar 2020 --> Jun 2020
- |||||||||| triamcinolone acetonide / Generic mfg., Zilretta (triamcinolone acetonide ER) / Flexion Therap
Journal: Physical and Chemical Compatibility of Extended-Release Triamcinolone Acetonide (TA-ER) with Common Local Anesthetics. (Pubmed Central) - Mar 20, 2020 Initiation date: Mar 2020 --> Jun 2020 These results demonstrate that lidocaine, bupivacaine, and ropivacaine are physically and chemically compatible with TA-ER, suggesting that local anesthetic solutions can be added to TA-ER preparations in clinical practice without adversely affecting TA-ER in vitro product characteristics.
- |||||||||| Zilretta (triamcinolone acetonide ER) / Pacira
Trial suspension: Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease (clinicaltrials.gov) - Mar 5, 2020 P3, N=65, Suspended, These results demonstrate that lidocaine, bupivacaine, and ropivacaine are physically and chemically compatible with TA-ER, suggesting that local anesthetic solutions can be added to TA-ER preparations in clinical practice without adversely affecting TA-ER in vitro product characteristics. Recruiting --> Suspended
- |||||||||| Zilretta (triamcinolone acetonide ER) / Pacira
New P1 trial: Effect of Zilretta Injection (clinicaltrials.gov) - Feb 6, 2020 P1, N=35, Not yet recruiting,
- |||||||||| Zilretta (triamcinolone acetonide ER) / Pacira
Trial completion date, Trial termination, Trial primary completion date: Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis (clinicaltrials.gov) - Nov 15, 2019 P3, N=70, Terminated, Active, not recruiting --> Completed Trial completion date: Dec 2020 --> Aug 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2020 --> Aug 2019; By Sponsor due to occurrences of incomplete study drug administration
- |||||||||| triamcinolone acetonide / Generic Mfg., Zilretta (triamcinolone acetonide ER) / Flexion
Journal: Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. (Pubmed Central) - Oct 8, 2019 Findings from a single-arm phase IIIb study indicated that a repeat administration of triamcinolone acetonide ER may be similarly efficacious to an initial injection without having deleterious effects on cartilage or other aspects of joint structure. Thus, triamcinolone acetonide ER expands the treatment options available for the management of OA pain of the knee.
- |||||||||| Zilretta (triamcinolone acetonide ER) / Flexion
Review, Journal: Update on novel pharmacological therapies for osteoarthritis. (Pubmed Central) - Aug 7, 2019 ...These include extended-release triamcinolone and conventional disease-modifying anti-rheumatic drugs (DMARDs) used in the management of rheumatoid arthritis; generally, DMARDs have not shown a benefit in treating OA...Disease-modifying osteoarthritis drugs (DMOADs) target key tissues in the OA pathophysiology process and aim to prevent structural progression; a number of putative DMOADs are in phase II development. There is preliminary evidence of structural improvement with some of these therapies but without concomitant symptom improvement, raising new considerations for future DMOAD trials.
- |||||||||| Zilretta (triamcinolone acetonide ER) / Pacira
Trial completion date, Trial primary completion date: Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis (clinicaltrials.gov) - Jun 11, 2019 P3, N=70, Active, not recruiting, FX006 provided significant, clinically meaningful pain reduction compared with saline-solution placebo at week 12 (primary end point). Trial completion date: Aug 2020 --> Dec 2020 | Trial primary completion date: Mar 2020 --> Jun 2020
- |||||||||| Zilretta (triamcinolone acetonide ER) / Pacira
Trial completion date, Trial primary completion date: Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee (clinicaltrials.gov) - Jan 22, 2019 P3, N=100, Recruiting, Therefore, the PEO based polymeric films were able to deliver TA into the back of the eye efficiently and for prolonged periods. Trial completion date: Nov 2019 --> Jun 2020 | Trial primary completion date: Jun 2019 --> Jan 2020
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