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Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

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ClinicalTrials.gov Identifier: NCT01058317
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : January 28, 2010
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary

Tracking Information
First Submitted Date  ICMJE January 27, 2010
First Posted Date  ICMJE January 28, 2010
Last Update Posted Date November 21, 2013
Study Start Date  ICMJE January 2010
Actual Primary Completion Date September 2010   (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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01058317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2010)
Improved voice quality [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (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 * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 20, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2010)
15
Actual Study Completion Date September 2010
Actual Primary Completion Date September 2010   (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
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 10 Years   (Child)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01058317
Other Study ID Numbers  ICMJE 09-10-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Massachusetts Eye and Ear Infirmary
Study Sponsor  ICMJE Massachusetts Eye and Ear Infirmary
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Hartnick, MD Massachusetts Eye and Ear Infirmary
PRS Account Massachusetts Eye and Ear Infirmary
Verification Date April 2012

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