Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

Phase3, Placebo Controlled, Randomized, Double-blinded, Long-Term, NSAID-Add-on, Clinical Trial of NPC-16 for Treatment of Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362711
• Other study ID #: NPC-16-2
• Status: Completed
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: January 28, 2017

Study information

• Verified date: February 2015
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: January 28, 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• dysmenorrhea

Exclusion Criteria:

• severe hepatopathy

• pregnant woman

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• NPC-16 Standard Dosing Regimen Group

• NPC-16 Continuous Dosing Regimen Group

• Placebo Group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score		52 weeks
Secondary	Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea		52 weeks