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Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

This study has been withdrawn prior to enrollment.
(No participants enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01058317
First Posted: January 28, 2010
Last Update Posted: November 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
  Purpose
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.

Condition Intervention Phase
Recurrent Respiratory Papillomatosis Drug: Propranolol Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Decreased number of surgeries [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Improved voice quality [ Time Frame: 3 months ]

Enrollment: 0
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Children treated with propranolol Drug: Propranolol
Propranolol 2mg/kg divided twice daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058317


Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Christopher Hartnick, MD Massachusetts Eye and Ear Infirmary
  More Information

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01058317     History of Changes
Other Study ID Numbers: 09-10-104
First Submitted: January 27, 2010
First Posted: January 28, 2010
Last Update Posted: November 21, 2013
Last Verified: April 2012

Keywords provided by Massachusetts Eye and Ear Infirmary:
respiratory, papilloma, pediatric, juvenile

Additional relevant MeSH terms:
Papilloma
Respiratory Tract Infections
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Infection
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents