ARISTOSPAN SUMMARY
A sterile suspension containing 20 mg/mL of micronized triamcinolone hexacetonide.
The intra-articular or soft tissue administration of Aristospan (triamcinolone hexacetonide injectable suspension, USP) 20 mg/mL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.
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NEWS HIGHLIGHTS
Published Studies Related to Aristospan (Triamcinolone Intra-Articular)
Gait patterns after intraarticular treatment of patients with osteoarthritis of the knee--hyaluronan versus triamcinolone: a prospective, randomized, doubleblind, monocentric study. [2009.04.16]
OBJECTIVE: Evaluation of gait performance and muscle activity patterns as well as clinical efficacy and safety after single intraarticular injection with hyaluronan compared with triamcinolone in patients with knee osteoarthritis... CONCLUSION: Single application of high-viscosity hyaluronan shows superior range of motion and pain reduction as well as improvement in clinical results. Even if there was a lack of significant differences compared to triamcinolone, this therapy classified as safe and effective in the short follow up.
Intramuscular botulinum toxin-A reduces hemiplegic shoulder pain: a randomized, double-blind, comparative study versus intraarticular triamcinolone acetonide. [2008.01]
BACKGROUND AND PURPOSE: Shoulder pain is frequent after stroke and interferes with the rehabilitative process and outcome. However, treatments used for hemiplegic shoulder pain are limited and largely ineffective. This prospective, randomized, double-blind controlled study was conducted to compare the efficacies of botulinum toxin type A (BoNT-A) and triamcinolone acetonide (TA) on hemiplegic shoulder pain and their effects on arm function in patients with stroke... CONCLUSIONS: Results from this study suggest that injection of BoNT-A into selected muscles of the shoulder girdle might provide more pain relief and ROM improvement than intraarticular steroid in patients with hemiplegic shoulder pain. A larger clinical trial needs to be undertaken to confirm the benefits of this approach.
A randomized controlled trial of intra-articular triamcinolone and/or physiotherapy in shoulder capsulitis. [2005.04]
OBJECTIVE: To assess the effectiveness of intra-articular triamcinolone injection and physiotherapy singly or combined in the treatment of adhesive capsulitis of the shoulder... CONCLUSION: Corticosteroid injection is effective in improving shoulder-related disability, and physiotherapy is effective in improving the range of movement in external rotation 6 weeks after treatment.
Treatment of de Quervain disease with triamcinolone injection with or without nimesulide. A randomized, double-blind, placebo-controlled trial. [2004.12]
BACKGROUND: There is uncertainty as to whether supplemental oral nonsteroidal anti-inflammatory medication improves the effectiveness of steroid injections in the treatment of de Quervain disease. We tested the hypothesis that there are no significant differences in the success rates when this condition is treated with triamcinolone injection with or without supplemental oral nimesulide... CONCLUSIONS: Supplemental oral administration of the nonsteroidal anti-inflammatory drug nimesulide does not improve the effectiveness of a single injection of triamcinolone acetonide in the treatment of de Quervain disease. Patients with crepitation in the first dorsal compartment during thumb extension or abduction are at increased risk for recurrence of this disease. LEVEL OF EVIDENCE: Therapeutic study, Level I-1b (randomized controlled trial [no significant difference but narrow confidence intervals]).
Triamcinolone acetonide and hexacetonide intra-articular treatment of symmetrical joints in juvenile idiopathic arthritis: a double-blind trial. [2004.10]
CONCLUSION: Even when TA is given at higher doses, TH is more effective and should be considered the drug of choice for intra-articular treatment of JIA.
Clinical Trials Related to Aristospan (Triamcinolone Intra-Articular)
Intralesional Steroids in the Treatment of Alopecia Areata [Recruiting]
Alopecia areata is a common form of hair loss which reportedly occurs in up to 1. 7% of the
population at some time in their life. Alopecia areata is apparently triggered when the
individual's own immune system attacks hair follicles on the scalp or body resulting in hair
loss ranging from single patches on the scalp (patch type alopecia areata) to loss of every
hair on the scalp and body (alopecia universalis). Currently, there are limited treatment
options for alopecia areata and unfortunately, the treatments utilized have never been
rigorously tested in a placebo controlled trial.
Triamcinolone (Kenalog) is a steroid solution that has been used as treatment for alopecia
areata for over 50 years. It is administered via injection into the scalp and appears to
have some efficacy for patients with mild to moderate alopecia areata. We currently do not
have objective data on the frequency of occurrence of successful regrowth, the duration of
response or the incidence of side effects. In addition, there is disagreement between
clinicians regarding the dose of intralesional triamcinolone (IL TAC) that is considered
most effective.
This study aims to determine the frequency of response to treatment with 3 concentrations of
IL TAC, 2. 5mg/ml, 5mg/ml or 10mg/ml as well as the duration of response and incidence of
side effects compared to treatment with placebo (sterile saline solution). After the 1st 6
months non or partial responders may be treated for 6 months with open label triamcinolone
at the dose deemed appropriate by the investigator.
We will also perform skin biopsies of the scalp and draw blood at selected time points in
order to examine the immunohistochemical/pathological response in scalp hair follicles and
the systemic circulation to treatment with IL TAC for alopecia areata.
A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema [Completed]
The study involves the enrollment of patients over 18 years of age with diabetic macular
edema involving the center of the macula who have not already been given maximal laser
treatment.
Patients with one study eye will be randomly assigned (stratified by prior laser) with equal
probability to one of five treatment groups:
1. Focal laser photocoagulation (modified ETDRS technique)
2. Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
3. Anterior peribulbar injection of 20 mg triamcinolone
4. Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser
5. Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser
For patients with two study eyes (both eyes eligible at the time of randomization), the
right eye (stratified by prior laser) will be randomly assigned with equal probabilities to
one of the five treatment groups listed above. If the right eye was assigned to laser only,
then the left eye will be assigned to one of the four triamcinolone groups above with equal
probability (stratified by prior laser). If the right eye was assigned to receive
triamcinolone, then the left eye will receive laser only.
Triamcinolone acetonide will be the corticosteroid utilized in this study. The triamcinolone
acetonide preparation to be used is Kenalog. Kenalog is manufactured by Bristol Myers Squibb
and is approved by the Food and Drug Administration for intramuscular use for a variety of
indications. Peribulbar injections of Kenalog have been used for a wide variety of ocular
conditions, particularly uveitis and post-cataract extraction cystoid macular edema, for
many years.
Two different triamcinolone regimens will be assessed in the study: 40 mg injected
posteriorly and 20 mg injected anteriorly. There is no indication of which treatment regimen
will be better. Although the injection behind the eye is more common than the injection near
the front of the eye, the injection near the front of the eye has less risk of injuring the
eye. However, it is possible that the injection near the front of the eye may increase eye
pressure more frequently. Little is known about which of the two injections decreases
macular edema and improves vision more often.
Patients enrolled into the study will be followed for three years and will have study visits
1 month, 2 months, 4 months, 8 months and annually after receiving their assigned study
treatment. For the first 8 months of the study, patients should only be retreated with their
randomized treatment. However, if the patient's visual acuity has decreased by 15 letters or
more, then any treatment may be given at the investigator's discretion. After completion of
the 8-month visit, treatment is at investigator discretion.
The primary objective of this study is to obtain estimates of efficacy and safety outcomes
for each of the treatment groups. These estimates will provide a basis for the sample size
estimation and hypothesis generation in a phase III trial.
Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis [Recruiting]
It is currently unknown whether or not the improvement in pain and function related to a
"steroid shot" for shoulder pain due to subacromial bursitis is important. This study seeks
to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone
significantly affect improvement in shoulder pain 6 weeks after injection.
Neoadjuvant TAC Plus or Minus Bevacizumab(AVF3299) [Active, not recruiting]
The purpose of this study is to evaluate the safety of the TAC-bevacizumab combination and
investigate whether changes in gene expression, or the expression of specific biomarkers,
are either predictive of response to bevacizumab or indicative of response.
Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis [Active, not recruiting]
This study is designed to determine the safety and tolerability of a single microinjection
of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who
have non-infectious uveitis.
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Page last updated: 2009-10-20
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