H001-A2
A Randomized, Double-Blinded, Negative- and Positive-Controlled Study for Evaluation of the Allergenicity of Amphadase® in Healthy Volunteers Using Intradermal Skin Test
Sponsor study identifier
interventional
253
1 country
5
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2012
Actual (reported)Study Completion
December 2012
Actual (reported)This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2012
Actual (reported)September 21, 2012
Actual (reported)November 2012
Actual (reported)December 2012
Actual (reported)January 20, 2017
Actual (reported)Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)
Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (\>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.
Up to 30 minutes after the final study drug injection
Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT)
Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (\>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.
Up to 30 minutes after the final study drug injection
Observed Wheal Size in the Per-Protocol Population (PPP)
Up to 30 minutes after the final study drug injection
Observed Erythema Size in the Per-Protocol Population (PPP)
Up to 30 minutes after the final study drug injection
Allergic Wheal Size in the Per-Protocol Population (PPP)
Up to 30 minutes after the final study drug injection
Allergic Erythema Size in the Per-Protocol Population (PPP)
Up to 30 minutes after the final study drug injection
Local Itchiness Rate in the Per-Protocol Population (PPP)
Up to 30 minutes after the final study drug injection
Intradermal injection of Amphadase (hyaluronidase 150 USP units/mL)
Intradermal injection of Histatrol (histamine base 0.1 mg/mL)
Intradermal injection of saline (0.02 mL)
Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms.
Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms.
Amphastar Site 0022
Eugene, Oregon, 97401, United States
Amphastar Site 0023
Lake Oswego, Oregon, 97035, United States
Amphastar Site 0026
Portland, Oregon, 97202, United States
Amphastar Site 0038
Renton, Washington, 98057, United States
Amphastar Site 0034
Seattle, Washington, 98115, United States
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.
Selina Su, MPH
A:mphastar Pharmaceuticals, Inc.
253 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2012
First Posted
September 21, 2012
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion
Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
November 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
January 20, 2017
Results First Posted
January 20, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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