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

Phase 3

• Conditions: Primary Dysmenorrhea
• Interventions: Drug: Pelubiprofen 45mg; Drug: Placebo

• Registration Number: NCT04541134
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Study First Posted: 2020-09-09
• Last Update Posted: 2020-09-09
• Study Start: 2020-09-30
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Placebo	-
Group 1	Pelubiprofen 45mg	-
Group 2	Pelubiprofen 45mg	-
Group 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
TOTPAR-8	Day 1	Time weighted sum of total pain relief
SPID-8	Day 1	Sum of pain intensity difference