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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until one hour after the test.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 hour after the provocation challenge.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 hour after the provocation challenge.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 hour after the provocation challenge. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

First stage - Skin test

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

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

Secondary outcome measures

Change in Nasal congestion score - (1 hour)

Change in Nasal congestion score - (48 hours)

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 / 1Eligibility criteria met

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Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

656 Previous Clinical Trials

413,408 Total Patients Enrolled

Media Library

NOVAPAK Nasal Packing (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05343650 — Phase 4

Shellfish Allergy Research Study Groups: Study arm

Shellfish Allergy Clinical Trial 2023: NOVAPAK Nasal Packing Highlights & Side Effects. Trial Name: NCT05343650 — Phase 4

NOVAPAK Nasal Packing (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05343650 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals is this medical experiment aiming to accomplish?

"The primary objective of this trial is to measure the impact of Novapak in the nasal cavity up until one hour after it has been administered. There are also three secondary objectives: evaluating change on a scale from zero (no congestion) to four (severe congestion) in terms of nasal congestion score at 1 hour, 24 hours and 48 hours post-Novapak administration."

Answered by AI

Is the eligibility for this investigation limited to individuals older than 40?

"This trial is exclusively open to participants between 18 and 60 years old. For those outside of this age bracket, there are 84 studies for younger patients, and 165 trials available for seniors over 65."

Answered by AI

To whom can this medical research be accessed?

"To enter this clinical trial, individuals with an allergy to shellfish and between the ages of 18-60 are preferred. Currently, there is a need for 20 participants in total."

Answered by AI

What could be the potential risks of placing NOVAPAK nasal packing in one's nostrils?

"Based on the Phase 4 status of NOVAPAK nasal packing in relation to its application within the nasal cavity, it has been determined that this treatment is safe and thus was awarded a score of 3."

Answered by AI

Is enrollment in this research project still open?

"According to clinicaltrials.gov, this medical trial is not currently recruiting patients. It was initially posted on 15th May 2022 and its most recent update took place 5 days prior. However, there are 267 other trials that may be of interest to potential participants as they are actively seeking enrolment at the moment."

Answered by AI

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