Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492
NCT ID: NCT02150213
Last Updated: 2016-12-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2014-08-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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BGG492
This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
MRI, CT or ultrasound was permitted if MRI was contraindicated
MRI/CT/ultrasound of abdomen
Dexamethasone Supression Test
Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol
Sonogram
Sonogram of the uterus (females only)
Biopsy
Uterine endometrial biopsy (females only)
BGG492
No study-drug was administered in this study
Interventions
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MRI, CT or ultrasound was permitted if MRI was contraindicated
MRI/CT/ultrasound of abdomen
Dexamethasone Supression Test
Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol
Sonogram
Sonogram of the uterus (females only)
Biopsy
Uterine endometrial biopsy (females only)
BGG492
No study-drug was administered in this study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events;
3. Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have been greater than 28 days
4. At least 1 year had to have elapsed since the patient received his or her last dose of BGG492.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Tallahassee, Florida, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Hoffman, New Jersey, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Bernau, , Germany
Novartis Investigative Site
Bielefeld, , Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Kehl-Kork, , Germany
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Kecskemét, , Hungary
Novartis Investigative Site
Szombathely, , Hungary
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Hlohovec, Slovak Republic, Slovakia
Novartis Investigative Site
Košice, Slovak Republic, Slovakia
Novartis Investigative Site
Banská Bystrica, Slovakia, Slovakia
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Countries
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Other Identifiers
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2013-003431-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBGG492A2216
Identifier Type: -
Identifier Source: org_study_id