Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
PHASE2
34 participants
INTERVENTIONAL
2020-05-22
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. The primary objective of this study is to evaluate the long-term safety of theophylline in patients with PHP.
2. The secondary objectives of this study are to evaluate changes in BMI, hormone resistance and epiphyseal closure associated with theophylline treatment of patients with PHP.
Study Design The proposed study is a single center, 24-month open label extension clinical trial for patients with PHP who complete the randomized clinical trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Open-label theophylline
Oral theophylline - either once daily capsule or q6h elixir.
Theophylline ER
Oral theophylline
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Theophylline ER
Oral theophylline
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. History of a cardiac arrhythmia (not including bradycardia)
3. Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT \>3x upper limit of normal)
4. Congestive heart failure
5. Current cigarette use or alcohol abuse
6. Pregnancy or intention to become pregnant during the next year
7. Active peptic ulcer disease
8. Current use of medications known to effect theophylline levels
9. History of hypersensitivity to theophylline or other medication components
10. Unable to comply with study procedures in the opinion of the investigator
2 Years
99 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ashley Shoemaker
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ashley Shoemaker
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ashley Shoemaker, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Research Group Facebook Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IND 133013 Extension Study
Identifier Type: -
Identifier Source: org_study_id