Theophylline as a Treatment for Children With Pseudohypoparathyroidism Type 1a (Albright Hereditary Osteodystrophy)
Completed · Phase 2
Conditions studied: Pseudohypoparathyroidism Type 1a, Albright Hereditary Osteodystrophy
In brief
This study will test an investigational drug, theophylline, in children with pseudohypoparathyroidism type 1a (PHP1a). This study involves a 3 day visit to the Vanderbilt Clinical Research Center.
Key facts
- Study ID
- NCT02463409
- Run by
- Vanderbilt University Medical Center
- People needed
- 6
- Starts
- 2015-06-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2017-06-26
Who can join
Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 10 to 21 years old
- English proficiency
- Clinical and genetic diagnosis of PHP1a
You may not qualify if…
- Use of a PDE inhibitor in the past 30 days
- History of a seizure disorder unrelated to hypocalcemia
- History of a cardiac arrhythmia (not including bradycardia)
- History of hepatic insufficiency
- AST or ALT >2x upper limit of normal
- Total bilirubin >1.5 x upper limit of normal (unless patient has a diagnosis of Gilbert's syndrome and no other causes leading to hyperbilirubinemia are identified)
- Congestive heart failure
- Cigarette use in the past 30 days
- Alcohol use within the past 24 hours
- Current pregnancy
- Untreated hypothyroidism (defined as free T4 level < 0.6 ng/dL or TSH >10 mcU/mL)
- Active peptic ulcer disease
- Fever >101 degrees in the past 24 hours
- Current use of medications known to effect theophylline levels (listed below)
- Severe sleep apnea requiring BiPAP
- Drugs with clinically significant drug interactions with theophylline:
- Allopurinol
- Cimetidine
- Ciprofloxacin
- Clarithromycin
- Enoxacin
- Ephedrine
- Erythromycin
- Estrogen
- Flurazepam
Where it is running
- Vanderbilt Unversity — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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