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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15 April 2024 |
Main ID: |
NCT03029429 |
Date of registration:
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18/01/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Theophylline Treatment for Pseudohypoparathyroidism
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Scientific title:
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Phase 2 Study of Theophylline Treatment for Pseudohypoparathyroidism |
Date of first enrolment:
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September 1, 2018 |
Target sample size:
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34 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03029429 |
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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Ashley Shoemaker, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University Medical Center |
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Name:
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Ashley Shoemaker, MD |
Address:
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Telephone:
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615-343-8116 |
Email:
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ashley.h.shoemaker@vanderbilt.edu |
Affiliation:
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Name:
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Jenny Leshko, RN |
Address:
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Telephone:
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6153438116 |
Email:
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jenny.leshko@vumc.org |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 13 years and above
2. Clinical diagnosis of PHP (per the EuroPHP network classification guidelines1):
Presence of PTH resistance or ectopic classification OR brachydactyly type E plus 2
minor criteria (TSH resistance, other hormonal resistance, developmental delay,
intrauterine or post-natal growth retardation, obesity/overweight, specific facial
features)
3. Obesity (BMI >95th percentile for age/gender and/or =30 kg/m2)
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. Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT >3x upper
limit of normal)
5. Congestive heart failure
6. Current cigarette use or alcohol abuse
7. Pregnancy or intention to become pregnant during the next year
8. Untreated hypothyroidism (defined as free thyroxine below the lower limit of normal)
9. Active peptic ulcer disease
10. Current use of medications known to effect theophylline levels
11. History of hypersensitivity to theophylline or other medication components
12. History of Major Depressive Disorder in the past 2 years, lifetime history of suicide
attempt, history of any suicidal behavior in the past month, history of other sever
psychiatric disorders (e.g. schizophrenia, bipolar disorder)
13. PHQ-9 score is =15 or suicidal ideation of type 4 or 5 (C-SSR) in the past month
14. Unable to comply with study procedures in the opinion of the investigator
Age minimum:
13 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pseudohypoparathyroidism
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Albright Hereditary Osteodystrophy
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Intervention(s)
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Drug: Theophylline
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Drug: Placebos
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Primary Outcome(s)
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Change in body mass index
[Time Frame: baseline and 52 weeks]
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Secondary Outcome(s)
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change in calcitriol dose
[Time Frame: baseline and 52 weeks]
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Change in insulinogenic index
[Time Frame: baseline and 52 weeks]
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change in levothyroxine dose
[Time Frame: baseline and 52 weeks]
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Secondary ID(s)
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IND 133103
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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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