Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT04139018 |
Date of registration:
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23/10/2019 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Timolol Gel for Epistaxis in Hereditary Hemorrhagic Telangiectasia
ETIC-HHT |
Scientific title:
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Efficacy of a Timolol Gel in the Care for Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia: A Double-Blinded, Randomized Controlled Trial |
Date of first enrolment:
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October 20, 2019 |
Target sample size:
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30 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT04139018 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Andrew M Peterson |
Address:
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Telephone:
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314-747-0910 |
Email:
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apeterson22@wustl.edu |
Affiliation:
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Name:
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Andrew M. Peterson |
Address:
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Telephone:
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314-747-0910 |
Email:
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apeterson22@wustl.edu |
Affiliation:
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Name:
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Jay F Piccirillo, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Washington University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Adults ages 20 and older
2. Confirmed clinical (meeting at least 3 of the 4 Curaçao Criteria) or genetic diagnosis
of HHT
3. Epistaxis Severity Score (ESS) = 4 and 2 or more nosebleeds per week with a cumulative
nosebleed duration of at least 5 minutes per week
4. Stable nasal hygiene and medical regimen for preceding 1 month
5. Stable epistaxis pattern over the preceding 3 months
Exclusion Criteria:
1. Contraindications for systemic ß adrenergic blocker administration
1. Hypersensitivity to ß adrenergic blockers
2. Asthma or bronchospasm
3. Congestive heart failure with LVEF <40%
4. Hereditary pulmonary arterial hypertension
5. Baseline bradycardia (HR <55 beats per minute)
6. Sick Sinus Syndrome
7. 2nd or 3rd degree heart block, left or right bundle branch block, or bifasicular
block
8. Uncontrolled diabetes mellitus (most recent HbA1c >9%) or diabetic ketoacidosis
within last 6 months
9. Hypotension (systolic blood pressure < 90)
2. Known hypersensitivity to timolol
3. Severe peripheral circulatory disturbances (Raynaud phenomenon)
4. Known intermediate or poor metabolizer variant of the liver enzyme CYP2D6
5. Current use of any of the following known strong CYP2D6 inhibitors: fluoxetine
(Prozac), paroxetine (Paxil), bupropion (Welbutrin), quinidine, quinine, ritonavir
(Norvir), and terbinafine (Lamisil)
6. Current use of the following other drugs known to pharmacodynamically interact with
timolol: diltiazem, verapamil, digoxin, digitalis, propafenone, disopyramide,
clonidine, flecainide, or lidocaine
7. Patients currently treated or who plan to initiate treatment with ß-blockers
8. Use of any anti-angiogenic medication in the last month prior to recruitment,
including bevacizumab, pazopanib, thalidomide, or lenalidomide
9. Illicit drug use, except marijuana
10. Known pheochromocytoma
11. Use of anticoagulants, antiplatelet, or fibrinolytic therapies within the last month
prior to recruitment, except for low-dose (81 mg or less) of aspirin
12. Pregnancy or planned pregnancy in the next 6 months or currently breastfeeding
13. Inability to read or understand English
14. Inability to complete 8 weeks of therapy for any reason
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hereditary Hemorrhagic Telangiectasia
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Intervention(s)
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Drug: Placebo Gel
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Drug: Timolol Gel
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Primary Outcome(s)
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Epistaxis Severity Scale
[Time Frame: Baseline to 8-week follow-up]
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Secondary Outcome(s)
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HHT endoscopic scale (HES)
[Time Frame: Baseline to 8-week follow-up]
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Mean Change in Hemoglobin
[Time Frame: Baseline to 8-week follow-up]
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Clinical Global Impression - Improvement (CGI-I) Score
[Time Frame: Baseline to 8-week follow-up]
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Secondary ID(s)
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201908160
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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