Acetaminophen and Diphenhydramine Only Product for Idiopathic Thrombocytopenic Purpura

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Texas Children's Hospital, Houston, TXIdiopathic Thrombocytopenic PurpuraAcetaminophen and Diphenhydramine Only Product - Drug
Eligibility
1 - 18
All Sexes
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Study Summary

This trial will test if it's possible to enroll children with ITP who are receiving IVIG for treatment, and if they're willing to participate in a scheduled medication regimen. They will also test if patients and families are able to stick to the schedule.

Eligible Conditions
  • Idiopathic Thrombocytopenic Purpura (ITP)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 12 months

12 months
Percentage of Eligible Patients Agreeing to Enrollment
Percentage of Enrolled Patients who Achieve Medication Adherence
Hour 72
Rate of Laboratory Evaluation with Platelet Count During Emergent Medical Evaluation
Cognitive Therapy
Rate of Return to Medical Care for Emergent Evaluation
Rates of IVIG-Associated Adverse Drug Events

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Scheduled post-IVIG medication
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Acetaminophen and Diphenhydramine Only Product · No Placebo Group · Phase 1

Scheduled post-IVIG medication
Drug
Experimental Group · 1 Intervention: Acetaminophen and Diphenhydramine Only Product · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
931 Previous Clinical Trials
5,989,295 Total Patients Enrolled
2 Trials studying Idiopathic Thrombocytopenic Purpura
312 Patients Enrolled for Idiopathic Thrombocytopenic Purpura

Eligibility Criteria

Age 1 - 18 · All Participants · 3 Total Inclusion Criteria

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Frequently Asked Questions

Are senior citizens eligible to take part in this clinical trial?

"According to the medical trial's requirements, patients wishing to be enrolled must have a minimum age of 1 Month and maximum age of 18." - Anonymous Online Contributor

Unverified Answer

For what maladies is Acetaminophen and Diphenhydramine Only Product commonly prescribed?

"Acetaminophen and Diphenhydramine Only Product is a prescribed medication utilized to relieve pain, catarrh, and rhinorrhoea." - Anonymous Online Contributor

Unverified Answer

Are applications for this investigation still being received?

"As of now, the clinical trial hosted on clinicialtrials.gov is recruiting patients and has been since October 20th 2021. The latest update to the study came in April 11th 2022." - Anonymous Online Contributor

Unverified Answer

Has the Acetaminophen and Diphenhydramine combination been certified by the FDA?

"The safety of Acetaminophen and Diphenhydramine Only Product is assessed at a 1 as this is an early stage clinical trial. There are minimal data points indicating its efficacy or risk profile." - Anonymous Online Contributor

Unverified Answer

What is the total number of research subjects involved in this experiment?

"Affirmative. The clinicaltrial.gov portal has documented that this trial, which was initially listed on October 20th 2021, is actively enrolling patients. Approximately 20 people are needed from one medical facility to participate in the study." - Anonymous Online Contributor

Unverified Answer

Who is eligible to participate in this experimental venture?

"Presently, this trial is accepting 20 sufferers of thrombocytopenia aged 1 Month to 18. All participants must have a confirmed diagnosis from the haematology team and be undergoing IVIG treatment as prescribed by their primary care provider, regardless if it was given in an outpatient or emergency setting." - Anonymous Online Contributor

Unverified Answer

What prior research has been undertaken on the effects of Acetaminophen and Diphenhydramine Only Product?

"At present, there are 104 studies concerning the combination of Acetaminophen and Diphenhydramine Only Product. Of these trials, 30 have moved into Phase 3. In addition to Taichung, Florida, over a thousand sites around the world are currently running research for this particular product." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.