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Trial record 22 of 1210 for:    HISTAMINE

Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP) (H001-A2)

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ClinicalTrials.gov Identifier: NCT01689363
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Amphastar Pharmaceuticals, Inc.

Brief Summary:
This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.

Condition or disease Intervention/treatment Phase
Allergic Skin Reaction Drug: Hyaluronidase Drug: Histamine Drug: Saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Screening
Official Title: A Randomized, Double-Blinded, Negative- and Positive-Controlled Study for Evaluation of the Allergenicity of Amphadase® in Healthy Volunteers Using Intradermal Skin Test
Study Start Date : September 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm H
Intradermal injection of Amphadase (hyaluronidase 150 USP units/mL)
Drug: Hyaluronidase
Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms.
Other Name: Amphadase®

Active Comparator: Arm P
Intradermal injection of Histatrol (histamine base 0.1 mg/mL)
Drug: Histamine
Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms.
Other Name: Histatrol®

Placebo Comparator: Arm N
Intradermal injection of saline (0.02 mL)
Drug: Saline
Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.




Primary Outcome Measures :
  1. Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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.

  2. Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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.


Secondary Outcome Measures :
  1. Observed Wheal Size in the Per-Protocol Population (PPP) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.

  2. Observed Erythema Size in the Per-Protocol Population (PPP) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.

  3. Allergic Wheal Size in the Per-Protocol Population (PPP) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.

  4. Allergic Erythema Size in the Per-Protocol Population (PPP) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.

  5. Local Itchiness Rate in the Per-Protocol Population (PPP) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.

  6. Erythema Responder Rate in the Per-Protocol Population (PPP) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.

  7. Observed Wheal Size in the Intent-to-Treat Population (ITT) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.

  8. Observed Erythema Size in the Intent-to-Treat Population (ITT) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.

  9. Allergic Erythema Size in the Intent-to-Treat Population (ITT) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.

  10. Local Itchiness Rate in the Intent-to-Treat Population (ITT) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.

  11. Erythema Responder Rate in the Intent-to-Treat Population (ITT) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.

  12. Allergic Wheal Size in the Intent-to-Treat Population (ITT) [ Time Frame: Up to 30 minutes after the final study drug injection ]
    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. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy volunteers of either gender; Those without clinically significant cardiovascular gastrointestinal, hepatic, neurological, psychiatric, endocrine, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results, assessed according to the judgment of the Principal Investigator. A non-inclusive list which would not be exclusionary and define healthy individual for the purposes of this study are:

  • 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:

  • Known allergy, hypersensitivity or contraindications to hyaluronidase, thimerosal, edetate disodium (EDTA);
  • Use of medications within a duration considered to interfere with skin testing.
  • Known dermographism which may interfere with skin testing.
  • Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689363


Locations
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United States, Oregon
Amphastar Site 0022
Eugene, Oregon, United States, 97401
Amphastar Site 0023
Lake Oswego, Oregon, United States, 97035
Amphastar Site 0026
Portland, Oregon, United States, 97202
United States, Washington
Amphastar Site 0038
Renton, Washington, United States, 98057
Amphastar Site 0034
Seattle, Washington, United States, 98115
Sponsors and Collaborators
Amphastar Pharmaceuticals, Inc.
Investigators
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Study Chair: Selina Su, MPH A:mphastar Pharmaceuticals, Inc.

Publications:

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Responsible Party: Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01689363     History of Changes
Other Study ID Numbers: API-H001-CLN-A2
First Posted: September 21, 2012    Key Record Dates
Results First Posted: January 20, 2017
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Amphastar Pharmaceuticals, Inc.:
hyaluronidase
enzymes with tissue spreading activity
allergic reaction
intradermal skin testing
Additional relevant MeSH terms:
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Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs