Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

This study has been withdrawn prior to enrollment.
(No participants enrolled)
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01058317
First received: January 27, 2010
Last updated: November 19, 2013
Last verified: April 2012

January 27, 2010
November 19, 2013
January 2010
September 2010   (final data collection date for primary outcome measure)
Decreased number of surgeries [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01058317 on ClinicalTrials.gov Archive Site
Improved voice quality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Respiratory Papillomatosis
Drug: Propranolol
Propranolol 2mg/kg divided twice daily
Experimental: Children treated with propranolol
Intervention: Drug: Propranolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
1 Year to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01058317
09-10-104
No
Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
Not Provided
Principal Investigator: Christopher Hartnick, MD Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP