Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)
NCT ID: NCT01689363
Last Updated: 2017-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
253 participants
INTERVENTIONAL
2012-09-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SCREENING
TRIPLE
Study Groups
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Arm H
Intradermal injection of Amphadase (hyaluronidase 150 USP units/mL)
Hyaluronidase
Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms.
Arm P
Intradermal injection of Histatrol (histamine base 0.1 mg/mL)
Histamine
Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms.
Arm N
Intradermal injection of saline (0.02 mL)
Saline
Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.
Interventions
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Hyaluronidase
Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms.
Histamine
Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms.
Saline
Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* hypothyroidism,
* stable hypertension except those subjects on beta blockers including ocular preparations,
* seasonal/perennial allergic rhinitis if able to wash out of antihistamines,
* stable, mild intermittent asthma (subjects using beta agonists as a monotherapy on an as-needed basis, excluding daily usage),
* migraine if not taking excluded medications,
* mild anxiety/depression if not taking excluded medications, and
* mild arthritic conditions if not taking excluded medications.
* Willingness and ability to sign an informed consent document;
* 18 - 80 years of age;
* Intact skin at the forearm ;
* Female participants are currently practicing effective birth control methods or abstinence.
Exclusion Criteria
* Use of medications within a duration considered to interfere with skin testing.
* Known dermographism which may interfere with skin testing.
* Pregnant or lactating women.
18 Years
80 Years
ALL
Yes
Sponsors
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Amphastar Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Selina Su, MPH
Role: STUDY_CHAIR
A:mphastar Pharmaceuticals, Inc.
Locations
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Amphastar Site 0022
Eugene, Oregon, United States
Amphastar Site 0023
Lake Oswego, Oregon, United States
Amphastar Site 0026
Portland, Oregon, United States
Amphastar Site 0038
Renton, Washington, United States
Amphastar Site 0034
Seattle, Washington, United States
Countries
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References
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Barr J, Kirkpatrick N, Dick A, Leonard L, Hawksworth G, Noble DW. Effects of adrenaline and hyaluronidase on plasma concentrations of lignocaine and bupivacaine after peribulbar anaesthesia. Br J Anaesth. 1995 Dec;75(6):692-7. doi: 10.1093/bja/75.6.692.
Brydon CW, Basler M, Kerr WJ. An evaluation of two concentrations of hyaluronidase for supplementation of peribulbar anaesthesia. Anaesthesia. 1995 Nov;50(11):998-1000. doi: 10.1111/j.1365-2044.1995.tb05940.x.
Ahluwalia HS, Lukaris A, Lane CM. Delayed allergic reaction to hyaluronidase: a rare sequel to cataract surgery. Eye (Lond). 2003 Mar;17(2):263-6. doi: 10.1038/sj.eye.6700243. No abstract available.
Agrawal A, McLure HA, Dabbs TR. Allergic reaction to hyaluronidase after a peribulbar injection. Anaesthesia. 2003 May;58(5):493-4. doi: 10.1046/j.1365-2044.2003.03154_17.x. No abstract available.
Kempeneers A, Dralands L, Ceuppens J. Hyaluronidase induced orbital pseudotumor as complication of retrobulbar anesthesia. Bull Soc Belge Ophtalmol. 1992;243:159-66.
Minning CA Jr. Hyaluronidase allergy simulating expulsive choroidal hemorrhage. Arch Ophthalmol. 1994 May;112(5):585-6. doi: 10.1001/archopht.1994.01090170029012. No abstract available.
Szepfalusi Z, Nentwich I, Dobner M, Pillwein K, Urbanek R. IgE-mediated allergic reaction to hyaluronidase in paediatric oncological patients. Eur J Pediatr. 1997 Mar;156(3):199-203. doi: 10.1007/s004310050582.
Allergy testing. American College of Physicians. Ann Intern Med. 1989 Feb 15;110(4):317-20. No abstract available.
Poulsen LK. In vivo and in vitro techniques to determine the biological activity of food allergens. J Chromatogr B Biomed Sci Appl. 2001 May 25;756(1-2):41-55. doi: 10.1016/s0378-4347(01)00070-6.
Howard A, Mercer P, Nataraj HC, Kang BC. Bevel-down superior to bevel-up in intradermal skin testing. Ann Allergy Asthma Immunol. 1997 Jun;78(6):594-6. doi: 10.1016/s1081-1206(10)63222-x.
Barbaud A, Reichert-Penetrat S, Trechot P, Jacquin-Petit MA, Ehlinger A, Noirez V, Faure GC, Schmutz JL, Bene MC. The use of skin testing in the investigation of cutaneous adverse drug reactions. Br J Dermatol. 1998 Jul;139(1):49-58. doi: 10.1046/j.1365-2133.1998.02313.x.
Fisher MM, Bowey CJ. Intradermal compared with prick testing in the diagnosis of anaesthetic allergy. Br J Anaesth. 1997 Jul;79(1):59-63. doi: 10.1093/bja/79.1.59.
Ruzicka T, Gerstmeier M, Przybilla B, Ring J. Allergy to local anesthetics: comparison of patch test with prick and intradermal test results. J Am Acad Dermatol. 1987 Jun;16(6):1202-8. doi: 10.1016/s0190-9622(87)70158-3.
Other Identifiers
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API-H001-CLN-A2
Identifier Type: -
Identifier Source: org_study_id
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