Last updated: 11/07/2018 16:29:33

The Sumatriptan and Naratriptan Pregnancy Registry

GSK study ID
EPI40050
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: The Sumatriptan and Naratriptan Pregnancy Registry
Trial description: The Sumatriptan and Naratriptan Pregnancy Registry
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Botto LD, Correa A, Erickson JD. Racial and temporal variations in the prevalence of heart defects. Pediatrics 2001;107:E32.
Centers for Disease Control and Prevention: Metropolitan Atlanta Congenital Defects Program Procedure Manual. July 1989 (Revised January 1998); A1-B11. To access a copy of the MACDP defect code, please go to http://www.cdc.gov/ncbddd/bd/macdp_resources.htm and click on the link to the .pdf file.
Correa A, Cragan JD, Kucik JE, et al. Metropolitan Atlanta Congenital Defects Program 40th Anniversary Edition Surveillance Report: Reporting Birth Defects Surveillance Data 1968-2003. Birth Defects Research (Part A) 2007; 79 (2):65-186.
Correa-Villaseñor A, Cragan J, Kucik J, O’Leary L, Siffel C, Williams L. The Metropolitan Atlanta Congenital Defects Program: 35 Years of Birth Defects Surveillance at the Centers for Disease Control and Prevention. Birth Defects Research (Part A) 2003; 67:617-624.
Eldridge RR, Ephross SA, Heffner CR, Tennis PS, Stender DM, White AD. Monitoring pregnancy outcomes following prenatal drug exposure through prospective pregnancy registries and passive surveillance: a pharmaceutical company commitment. Prim Care Update Ob Gyns. 1998; 5(4): 190-191.
Eldridge RR, Ephross SA, Heffner CR, Tennis PS, Stender DM, White AD. Monitoring pregnancy outcomes following prenatal drug exposure through prospective pregnancy registries and passive surveillance: a pharmaceutical company commitment. Prim Care Update Ob Gyns. 1998; 5(4): 90-191.
Eldridge RR, Ephross SA. Monitoring birth outcomes in the sumatriptan pregnancy registry. Prim Care Update Ob Gyns. 1998; 5(4): 190.
Eldridge RR, Ephross SA. Monitoring birth outcomes in the sumatriptan pregnancy registry. Prim Care Update Ob Gyns. 1998; 5(4): 190.
Kallen B, Lygner PE. Delivery outcome in women who used drugs for migraine during pregnancy with special reference to Sumatriptan. Headache 2001;41:351-356.
Reiff-Eldridge RR, Heffner CR, Ephross SA, Tennis PS, White AD, Andrews EB. Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment. Am J Obstet Gynaecol. 2000; 182 (1 Pt 1): 159-63.
Reiff-Eldridge RR, Heffner CR, Ephross SA, Tennis PS, White AD, Andrews EB. Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment. Am J Obstet Gynaecol. 2000; 182 (1 Pt 1): 159-63.
Roguin N, Du ZD, Barak M, Nasser N, Hershkowitz S, Milgram E. High prevalence of muscular ventricular septal defect in neonates. J Am Coll Cardiol 1995;26:1545-1548.
Sumatriptan and Naratriptan Pregnancy Registry. Interim Report 1 January 1996 through 31 October 2006. Issued February 2007. Available at: http://pregnancyregistry.gsk.com/index.html
Sumatriptan and Naratriptan Pregnancy Registry. Interim Report 1 January 1996 through 31 October 2006. Issued February 2007. Available at: http://pregnancyregistry.gsk.com/index.html
Medical condition
Migraine Disorders
Product
naratriptan
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Not applicable
Phase
4

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Not applicable

Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website