Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis - Tabular View

Tracking Information
First Received Date ^ICMJE	January 27, 2010
Last Updated Date	January 27, 2010
Start Date ^ICMJE	January 2010
Estimated Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 27, 2010)	Decreased number of surgeries [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: January 27, 2010)	Improved voice quality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
Official Title ^ICMJE	Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
Brief 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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase II Phase III
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Recurrent Respiratory Papillomatosis
Intervention ^ICMJE	Drug: Propranolol Propranolol 2mg/kg divided twice daily
Study Arms	Experimental: Children treated with propranolol Intervention: Drug: Propranolol
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	15
Estimated Completion Date	March 2011
Estimated Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	1 Year to 10 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT01058317
Other Study ID Numbers ^ICMJE	09-10-104
Has Data Monitoring Committee	Yes
Responsible Party	Christopher Hartnick, Associate Professor, Otolaryngology, Massachusetts Eye and Ear Infirmary
Study Sponsor ^ICMJE	Massachusetts Eye and Ear Infirmary
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Massachusetts Eye and Ear Infirmary
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP