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WithdrawnNCT01058317Updated Nov 21, 2013

Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

A Phase 2/3 interventional study of Propranolol in Recurrent Respiratory Papillomatosis, sponsored by Massachusetts Eye and Ear Infirmary. Withdrawn. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2013-11-21.

Sponsored by Massachusetts Eye and Ear Infirmary · Phase 2/3, Interventional, and Treatment

Why this study was withdrawn
No participants enrolled
Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
1 Year to 10 Years
Sex
All
01

Study summary

Juvenile onset recurrent respiratory papillomatosis (JORRP) is a rare, difficult to treat, benign tumor of the pediatric airway. Current therapy is mainly surgical, but in a significant portion of patients adjuvant therapy is required to control the disease process. Although multiple adjuvant medical therapies have been tried, success has been limited. We have seen some success in a limited amount of patients using orally administered propranolol. Our goal is to enroll a larger cohort of patients to determine the effectiveness of propranolol as an adjuvant therapy for JORRP.

02

Conditions studied

  • Recurrent Respiratory Papillomatosis

Keywords

  • respiratory, papilloma, pediatric, juvenile
03

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

Browse Respiratory Tract Infections studies →

Lead sponsor

Massachusetts Eye and Ear Infirmary is the lead sponsor of 99 studies on the registry; 23 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 6 (46%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Biopsy proven with appropriate Human Papilloma Virus typing Recurrent Respiratory Papilloma
    1. Child under age 10
    1. Informed consent and where appropriate informed assent
    1. Children who have undergone at least 4 documented surgical interventions in the past year.

Exclusion criteria

Exclusion Criteria:

  • Parental or child refusal to participate
  • Heart failure
  • Atrio-ventricular heart block
  • Cardiac anomalies
  • Low resting heart rate
  • Low resting blood pressure
  • Wolff-Parkinson White Syndrome
  • Unexplained syncope
  • Asthma or Reactive airway disease
  • Renal or liver failure
  • Expected long fasting periods, >12 hours
  • Diabetes Mellitus
  • Hypersensitivity to propranolol
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Children treated with propranolol

    Drug: Propranolol

Interventions

  • DrugPropranolol

    Propranolol 2mg/kg divided twice daily

06

What researchers measure

Primary outcomes

  1. Decreased number of surgeries

    Time frame: 3 months

Secondary outcomes

  1. Improved voice quality

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01058317
Lead sponsor
Massachusetts Eye and Ear Infirmary
Responsible party
Sponsor
First posted
Jan 28, 2010
Start date
Jan 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Nov 21, 2013

Study contacts

Christopher Hartnick, MD
principal investigator · Massachusetts Eye and Ear Infirmary

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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