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NCT04541134 Clinical Trial

Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:
A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04541134
Other study ID # DW9801-303
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date September 30, 2020
Est. completion date August 30, 2021

Study information
Verified date September 2020
Source Daewon Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients with Primary Dysmenorrhea

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 44 Years
Eligibility Inclusion Criteria:

- Female patients, age between 19 years to 44years

- Patients with menstrual pain over 4 out of 6 menstrual cycles before screening

- Patients with moderate or severe menstrual pain for recent 2 menstrual cycles

- Patients with regular menstrual cycles(28±7 days) for a year

Exclusion Criteria:

- Patients diagnosed or suspected of secondary dysmenorrhea

- Previous adverse reaction or known allergy to NSAIDs

- Breast feeding woman

- Patients who are not willing to use proper contraception during clinical trial period

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pelubiprofen 45mg
Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)
• Placebo
Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Daewon Pharmaceutical Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary TOTPAR-8 Time weighted sum of total pain relief Day 1
Primary SPID-8 Sum of pain intensity difference Day 1
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