View Clinical Trial (Medical Research Study)
The Savella Pregnancy Registry
| City: |
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Wilmington |
| State: |
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North Carolina |
| Zip Code: |
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28405 |
| Conditions: |
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Fibromyalgia |
| Purpose: |
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The Savella Pregnancy Registry is a US based registry designed to monitor pregnancies
exposed to Savella (milnacipran HCI). This is an observational, exposure-registration and
follow-up registry designed primarily to estimate the prevalence of major congenital
anomalies, and secondarily to estimate the prevalence of recognized spontaneous abortions,
stillbirths, induced abortions, minor congenital anomalies, and any serious adverse
pregnancy outcomes among pregnancies exposed to Savella as well as adverse outcomes observed
during the first year of life in off-springs born from these exposed pregnancies. Live
offspring are followed from birth until age one. The Savella Pregnancy Registry is sponsored
by Forest Laboratories Inc. (Forest) and managed by INC Research, LLC.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Females exposed to Savella during pregnancy
- Willing to provide verbal consent
- 18 y/o, US citizen
Exclusion Criteria:
- Male
- Under 18 y/o
- Females not pregnant, not exposed to savella
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| NCT ID: |
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NCT01026077 |
| Primary Contact: |
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Principal Investigator
Susan Roberts, RN, PhD
Sr. Epidemiologist
Pamela Meador
Phone: 877-643-3010
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| Backup Contact: |
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N/A |
| Location Contact: |
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Wilmington, North Carolina 28405
United States
Jan McLean
Phone: 910-679-1572
Email: pregnancyregistries@incresearch.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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