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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01120431
Other study ID # 1838-008
Secondary ID
Status Withdrawn
Phase Phase 4
First received May 7, 2010
Last updated May 5, 2017
Start date May 2010
Est. completion date May 2010

Study information

Verified date May 2017
Source Baxter Healthcare Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender All
Age group 2 Months to 2 Years
Eligibility Inclusion Criteria:

- Male or female and aged 2 months to 2 years

- Presenting to ED with mild or moderate dehydration

- Candidate for both parenteral and oral rehydration therapies

- Healthy, except for underlying etiology for dehydration

- Naive to ORT or having received attempted ORT at home for current occurrence of dehydration.

- Pre-dehydration body weight greater than 5th percentile for age

Exclusion Criteria:

- Severe dehydration

- Shock or a life-threatening situation

- Any condition precluding SC infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for SC infusion

- Medical reason or condition precluding administration of ORT

- Indwelling IV catheter (except one intended only for laboratory sample collection) or anticipated need for IV therapy during the study

- Anticipated need for hospitalization(other than for rehydration)

- Known hypersensitivity to hyaluronidase or any other ingredient in the formulation of hylenex recombinant

- Known hyponatremia, hypernatremia or hypokalemia

- Medical condition likely to interfere with ability to fully complete protocol-specified interventions and assessments, or likely to prolong need for medical attention beyond that required for rehydration

- Participation in an investigational drug or device study within 30 days before participation in this study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Oral rehydration fluid
Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes
Drug:
Isotonic hydration fluid and recombinant human hyaluronidase
Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Baxter Healthcare Corporation Halozyme Therapeutics

Outcome

Type Measure Description Time frame Safety issue
Primary Total resource utilization in the ED 2 to 8 hours
Secondary Rate of successful rehydration in the ED Clinical judgement of adequate hydration, and either: 1) stable or increased body weight or 2) urine production 2 to 8 hours
Secondary Time to ED discharge 2 to 8 hours
Secondary Amount of rehydration fluid administered 2 to 8 hours
Secondary Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver 2 to 8 hours
Secondary Occurrence of infusion site pain or other local reactions 2 to 8 hours
Secondary Occurrence of other adverse events 7 days
Secondary Vital signs Blood pressure, heart rate, respiratory rate, temperature 2 to 8 hours
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