Wellnara Post-marketing Surveillance in Japan

Osteoporosis, Postmenopausal Clinical Trial

— WELLNARA  

Official title:

Drug Use Investigation of Wellnara Tablet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401114
• Other study ID #: 15041
• Status: Completed
• Phase: N/A
• First received: July 22, 2011
• Last updated: September 25, 2015
• Start date: March 2009
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Wellnara for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Wellnara in clinical practice. A total 400 patients will be recruited and followed 3 years since starting Wellnara administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who received Wellnara for postmenopausal osteoporosis

Exclusion Criteria:

• Patients who are contraindicated based on the product label

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• E2/LNG oral (Wellnara, BAY86-5029)
Patients in daily life treatment receiving Wellnara for postmenopausal osteoporosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions and serious adverse events in subject who received Wellnara		After Wellnara administration, up to 3 years	Yes
Secondary	Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Wellnara		At baseline and after Wellnara administration, up to 3 years	Yes
Secondary	Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse		At baseline and after Wellnara treatment, up to 3 years	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here and search for websynopsis results based on ICH-E3 format