Allergic Skin ReactionPhase 2H001-A2NCT01689363
Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)
A Phase 2 study testing Hyaluronidase, Histamine and Saline in people with Allergic Skin Reaction, run by Amphastar Pharmaceuticals, Inc. at 5 sites in United States.
Trial summary
This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Skin Reaction
- What is being tested?
- Hyaluronidase, Histamine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2012to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Amphastar Site 0022
Eugene, Oregon, 97401
Amphastar Site 0023
Lake Oswego, Oregon, 97035
Amphastar Site 0026
Portland, Oregon, 97202
Amphastar Site 0038
Renton, Washington, 98057
Amphastar Site 0034
Seattle, Washington, 98115
About this study
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
This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.
- Conditions
- Allergic Skin Reaction
- Being tested
- Hyaluronidase, Histamine, Saline
- Keywords
- hyaluronidase, enzymes with tissue spreading activity, allergic reaction, intradermal skin testing
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyaluronidaseDrug
Also called Amphadase®
Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms.
HistamineDrug
Also called Histatrol®
Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms.
SalineDrug
Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.
| Study group | Role | What they receive |
|---|---|---|
| Arm H | Experimental | Intradermal injection of Amphadase (hyaluronidase 150 USP units/mL) Receives: Drug: Hyaluronidase |
| Arm P | Active comparator | Intradermal injection of Histatrol (histamine base 0.1 mg/mL) Receives: Drug: Histamine |
| Arm N | Placebo comparator | Intradermal injection of saline (0.02 mL) Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 30 minutes after the final study drug injection
Secondary outcomes (12)
Observed Wheal Size 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. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.
Measured: Up to 30 minutes after the final study drug injection
Observed Erythema Size 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. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.
Measured: Up to 30 minutes after the final study drug injection
Allergic Wheal Size 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. 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.
Measured: Up to 30 minutes after the final study drug injection
Allergic Erythema Size 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. 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.
Measured: Up to 30 minutes after the final study drug injection
Local Itchiness Rate 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. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.
Measured: Up to 30 minutes after the final study drug injection
Erythema Responder Rate 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. 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.
Measured: Up to 30 minutes after the final study drug injection
Observed Wheal Size 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. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.
Measured: Up to 30 minutes after the final study drug injection
Observed Erythema Size 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. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.
Measured: Up to 30 minutes after the final study drug injection
Allergic Erythema Size 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. 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.
Measured: Up to 30 minutes after the final study drug injection
Local Itchiness Rate 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. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.
Measured: Up to 30 minutes after the final study drug injection
Erythema Responder Rate 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. 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.
Measured: Up to 30 minutes after the final study drug injection
Allergic Wheal Size 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. 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.
Measured: Up to 30 minutes after the final study drug injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Allergic Skin ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Selina Su, MPH, Study chair, A:mphastar Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689363
- Sponsor's protocol ID
- API-H001-CLN-A2
- Acronym
- H001-A2
- Status last verified
- Jan 2017
- First submitted
- 13 Sep 2012
- Last updated
- 20 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 8672315Brydon 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.
PubMed 8678264Ahluwalia 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.
PubMed 12640426Agrawal 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.
PubMed 12694021Kempeneers A, Dralands L, Ceuppens J. Hyaluronidase induced orbital pseudotumor as complication of retrobulbar anesthesia. Bull Soc Belge Ophtalmol. 1992;243:159-66.
PubMed 1302146Minning 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.
PubMed 8185511Szepfalusi 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.
PubMed 9083759Allergy testing. American College of Physicians. Ann Intern Med. 1989 Feb 15;110(4):317-20. No abstract available.
PubMed 2578014Poulsen 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.
PubMed 11419727Howard 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.
PubMed 9207725Barbaud 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.
PubMed 9764148Fisher 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.
PubMed 9301390Ruzicka 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.
PubMed 3597862
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01689363
- Acronym / sponsor ID
- H001-A2 / API-H001-CLN-A2
- Conditions
- Allergic Skin Reaction
- Keywords
- hyaluronidase, enzymes with tissue spreading activity, allergic reaction, intradermal skin testing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Posted 20 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm H | Experimental | Drug: HyaluronidaseIntradermal injection of Amphadase (hyaluronidase 150 USP units/mL) |
| Arm P | Active comparator | Drug: HistamineIntradermal injection of Histatrol (histamine base 0.1 mg/mL) |
| Arm N | Placebo comparator | Drug: SalineIntradermal injection of saline (0.02 mL) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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),
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyaluronidaseAlso: Amphadase®Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms. | Drug | Arm H |
| HistamineAlso: Histatrol®Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms. | Drug | Arm P |
| SalineSubjects received one intradermal injection of 0.02 mL saline at one random site on their forearm. | Drug | Arm N |
Primary outcome
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.
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.
12 secondary outcomes
Observed Wheal Size in the Per-Protocol Population (PPP)
Time frame: Up to 30 minutes after the final study drug injection
Observed Erythema Size in the Per-Protocol Population (PPP)
Time frame: Up to 30 minutes after the final study drug injection
Allergic Wheal Size in the Per-Protocol Population (PPP)
Time frame: Up to 30 minutes after the final study drug injection
Allergic Erythema Size in the Per-Protocol Population (PPP)
Time frame: Up to 30 minutes after the final study drug injection
Local Itchiness Rate in the Per-Protocol Population (PPP)
Time frame: Up to 30 minutes after the final study drug injection
Erythema Responder Rate in the Per-Protocol Population (PPP)
Time frame: Up to 30 minutes after the final study drug injection
Observed Wheal Size in the Intent-to-Treat Population (ITT)
Time frame: Up to 30 minutes after the final study drug injection
Observed Erythema Size in the Intent-to-Treat Population (ITT)
Time frame: Up to 30 minutes after the final study drug injection
Allergic Erythema Size in the Intent-to-Treat Population (ITT)
Time frame: Up to 30 minutes after the final study drug injection
Local Itchiness Rate in the Intent-to-Treat Population (ITT)
Time frame: Up to 30 minutes after the final study drug injection
Erythema Responder Rate in the Intent-to-Treat Population (ITT)
Time frame: Up to 30 minutes after the final study drug injection
Allergic Wheal Size in the Intent-to-Treat Population (ITT)
Time frame: Up to 30 minutes after the final study drug injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8672315Barr 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.
- Background: PubMed 8678264Brydon 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.
- Background: PubMed 12640426Ahluwalia 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.
- Background: PubMed 12694021Agrawal 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.
- Background: PubMed 1302146Kempeneers A, Dralands L, Ceuppens J. Hyaluronidase induced orbital pseudotumor as complication of retrobulbar anesthesia. Bull Soc Belge Ophtalmol. 1992;243:159-66.
- Background: PubMed 8185511Minning 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.
- Background: PubMed 9083759Szepfalusi 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.
- Background: PubMed 2578014Allergy testing. American College of Physicians. Ann Intern Med. 1989 Feb 15;110(4):317-20. No abstract available.
- Background: PubMed 11419727Poulsen 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.
- Background: PubMed 9207725Howard 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.
- Background: PubMed 9764148Barbaud 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.
- Background: PubMed 9301390Fisher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selina Su, MPH study chair
A:mphastar Pharmaceuticals, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyaluronidase, Histamine and Saline in people with Allergic Skin Reaction, run by Amphastar Pharmaceuticals, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP) (time frame: Up to 30 minutes after the final study drug injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01689363, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.