Recurrent Respiratory PapillomatosisPhase 2/3NCT01058317
Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
A Phase 2/3 study testing Propranolol in people with Recurrent Respiratory Papillomatosis, run by Massachusetts Eye and Ear Infirmary.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Recurrent Respiratory Papillomatosis
- What is being tested?
- Propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Sep 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Parental or child refusal to participate
- Heart failure
- Atrio-ventricular heart block
- Cardiac anomalies
- Low resting heart rate
- Low resting blood pressure
Show all 13Show fewer
- 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
About this study
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.
- Conditions
- Recurrent Respiratory Papillomatosis
- Being tested
- Propranolol
- Keywords
- respiratory, papilloma, pediatric, juvenile
- Medical subject headings
- Recurrent respiratory papillomatosis, Papilloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Propranolol 2mg/kg divided twice daily
| Study group | Role | What they receive |
|---|---|---|
| Children treated with propranolol | Experimental | Not described Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased number of surgeries
Measured: 3 months
Secondary outcomes (1)
Improved voice quality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Respiratory PapillomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Hartnick, MD, Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058317
- Sponsor's protocol ID
- 09-10-104
- Status last verified
- Apr 2012
- First submitted
- 27 Jan 2010
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
- ClinicalTrials.gov ID
- NCT01058317
- Acronym / sponsor ID
- 09-10-104
- Conditions
- Recurrent Respiratory Papillomatosis
- Keywords
- respiratory, papilloma, pediatric, juvenile
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children treated with propranolol | Experimental | Drug: Propranolol |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Parental or child refusal to participate
- Heart failure
- Atrio-ventricular heart block
- Cardiac anomalies
- Low resting heart rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololPropranolol 2mg/kg divided twice daily | Drug | Children treated with propranolol |
Primary outcome
Decreased number of surgeries
Time frame: 3 months
1 secondary outcome
Improved voice quality
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Hartnick, MD principal investigator
Massachusetts Eye and Ear Infirmary
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Propranolol in people with Recurrent Respiratory Papillomatosis, run by Massachusetts Eye and Ear Infirmary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased number of surgeries (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.