Theophylline as a Treatment for Children With Pseudohypoparathyroidism Type 1a (Albright Hereditary Osteodystrophy)
Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pseudohypoparathyroidism Type 1a; Albright Hereditary Osteodystrophy
Intervention: Theophylline (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s): Ashley H Shoemaker, MD, MSCI, Principal Investigator, Affiliation: Vanderbilt University
Overall contact: Ashley H Shoemaker, MD, MSCI, Phone: 615-343-8116, Email: Ashley.H.Shoemaker@Vanderbilt.edu
Summary
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.
Clinical Details
Official title: Effects of Theophylline on cAMP Signaling in Children With Pseudohypoparathyroidism Type 1a
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Urine cAMP
Secondary outcome: Resting Energy Expenditure (REE)Apnea Hypopnea Index (AHI)
Eligibility
Minimum age: 10 Years.
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age 10 to 21 years old
2. English proficiency
3. Clinical and genetic diagnosis of PHP1a
Exclusion Criteria:
1. Use of a PDE inhibitor in the past 30 days
2. History of a seizure disorder unrelated to hypocalcemia
3. History of a cardiac arrhythmia (not including bradycardia)
4. History of hepatic insufficiency
5. AST or ALT >2x upper limit of normal
6. 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)
7. Congestive heart failure
8. Cigarette use in the past 30 days
9. Alcohol use within the past 24 hours
10. Current pregnancy
11. Untreated hypothyroidism (defined as free T4 level < 0. 6 ng/dL or TSH >10 mcU/mL)
12. Active peptic ulcer disease
13. Fever >101 degrees in the past 24 hours
14. Current use of medications known to effect theophylline levels (listed below)
15. Severe sleep apnea requiring BiPAP
Drugs with clinically significant drug interactions with theophylline:
- Allopurinol
- Cimetidine
- Ciprofloxacin
- Clarithromycin
- Enoxacin
- Ephedrine
- Erythromycin
- Estrogen
- Flurazepam
- Fluvoxamine
- Lithium
- Lorazepam
- Methotrexate
- Midazolam
- Pentoxifylline
- Propranolol
- Rifampin
- Sulfinpyrazone
- Tacrine
- Thiabendazole
- Ticlopidine
- Troleandomycin
- Verapamil
Locations and Contacts
Ashley H Shoemaker, MD, MSCI, Phone: 615-343-8116, Email: Ashley.H.Shoemaker@Vanderbilt.edu
Vanderbilt Unversity, Nashville, Tennessee 37232, United States; Recruiting Ashley Shoemaker, MD, Phone: 615-343-8116, Email: Ashley.H.Shoemaker@vanderbilt.edu Margo Black, MSN, Phone: 615-343-5846, Email: margo.black@vanderbilt.edu Ashley Shoemaker, MD, Principal Investigator
Additional Information
Vanderbilt PHP Research Page
Related publications: Landreth H, Malow BA, Shoemaker AH. Increased Prevalence of Sleep Apnea in Children with Pseudohypoparathyroidism Type 1a. Horm Res Paediatr. 2015;84(1):1-5. doi: 10.1159/000381452. Epub 2015 Apr 23. Shoemaker AH, Lomenick JP, Saville BR, Wang W, Buchowski MS, Cone RD. Energy expenditure in obese children with pseudohypoparathyroidism type 1a. Int J Obes (Lond). 2013 Aug;37(8):1147-53. doi: 10.1038/ijo.2012.200. Epub 2012 Dec 11.
Starting date: June 2015
Last updated: June 2, 2015
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