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NOVAPAK for Shellfish Allergy

Phase 4

Waitlist Available

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged 18-60

Be between 18 and 65 years old

Must not have

Presence of beta-blocker medications.

Severe cerebrovascular disease: history of stroke or severe carotid stenosis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until one hour after the test.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is investigating whether a commonly used medical material is safe for people with shellfish allergies.

Who is the study for?

This trial is for adults aged 18-60 with a confirmed shellfish allergy. Candidates must have had a previous allergic reaction to shellfish or convincing clinical history and testing. People taking beta-blockers, those with severe lung, heart, or cerebrovascular diseases, pregnant individuals, and patients who can't stop antihistamines or prednisone are excluded.

What is being tested?

The study tests the safety of NOVAPAK nasal packing in people allergic to shellfish. NOVAPAK will be applied both on the forearm and inside the nasal cavity to see if it's safe for use after nosebleeds or surgery despite its shellfish-derived materials.

What are the potential side effects?

While no specific side effects are listed due to this being a safety trial, potential risks may include local reactions at application sites such as itching or rash, especially given the participants' known allergies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking beta-blocker medications.

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I have had a stroke or have severe narrowing of my neck arteries.

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I have severe asthma or obstructive lung disease.

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I have a history of serious heart conditions.

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I have had severe allergic reactions to shellfish or have a condition called systemic mastocytosis.

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I cannot stop taking antihistamines or prednisone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until one hour after the test

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until one hour after the test

This trial's timeline: 3 weeks for screening, Varies for treatment, and until one hour after the test for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

First stage - Skin test

Second stage - Novapak in the nasal cavity (1 hour)

Second stage - Novapak in the nasal cavity (48 hours)

Secondary study objectives

Change in Nasal congestion score - (1 hour)

Change in Nasal congestion score - (48 hours)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study armExperimental Treatment2 Interventions

Stage 1 After shellfish allergy is confirmed through the skin prick test and IgE analysis, Novapak packing will be applied to the patient's skin for 30 minutes on the anterior aspect of the patients' non-dominant arm. In case of pre-existing wounds, it will be applied to the other forearm. Participants will then be monitored for 1 hour, and any- reaction will be documented. In case of any symptoms of an allergic reaction, their study participation will be terminated. Stage 2 If no allergic symptoms are observed in stage 1, the patient's nose will be anesthetized with topical lidocaine. A piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes. After removal, the participant will be monitored in the clinic for an hour. Any allergic reaction will be documented, including increased nasal congestion, rhinorrhea, or pruritis.

0 / 7Eligibility criteria met