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| Sponsor: | NPS Pharmaceuticals |
|---|---|
| Information provided by: | NPS Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00732615 |
Purpose
Use of PTH (1-84) a recombinant (man-made) hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypoparathyroidism |
Drug: Placebo Drug: NPSP558 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism |
| Estimated Enrollment: | 110 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo: Placebo Comparator
Sterile water for injection
|
Drug: Placebo
placebo for subcutaneous injection
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50, 75, 100 mcg NPSP 558: Experimental
Initial dose of 50mcg, to be titrated up to 75mcg and then 100mcg dependent upon response
|
Drug: NPSP558
Parathyroid hormone 50, 75, or 100 micrograms injectable subcutaneously daily
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Patients with a history of hypoparathyroidism will be randomized to receive placebo or study drug for 24 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically, calcium levels in the blood and urine). In addition, the patients' intake of Vitamin D and calcium will be measured.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients who meet all of the following inclusion criteria can be enrolled and potentially randomized into this study:
Exclusion Criteria
Patients who have any of the following during the screening visit are not eligible for enrollment in this study:
Contacts and Locations| Contact: Susan Kusek | 908-450-5300 | skusek@npsp.com |
| Contact: Tony Sileno | 908-450-5300 | asileno@npsp.com |
Show 32 Study Locations| Study Director: | Roger Garceau, M.D. | NPS Pharmaceuticals |
More Information
| Responsible Party: | NPS Pharmaceuticals, Inc. ( NPS Pharmaceuticals, Inc. ) |
| ClinicalTrials.gov Identifier: | NCT00732615 History of Changes |
| Other Study ID Numbers: | CL1-11-040 |
| Study First Received: | August 8, 2008 |
| Last Updated: | August 31, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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Hypoparathyroidism |
|
Hypoparathyroidism Parathyroid Diseases Endocrine System Diseases |