NCT04541134

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

September 1, 2020

Last Update Submit

September 1, 2020

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

  • TOTPAR-8

    Time weighted sum of total pain relief

    Day 1

  • SPID-8

    Sum of pain intensity difference

    Day 1

Study Arms (2)

Group 1

OTHER
Drug: Pelubiprofen 45mgDrug: Placebo

Group 2

OTHER
Drug: Pelubiprofen 45mgDrug: Placebo

Interventions

Pelubiprofen 45mgDRUG

Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)

Group 1Group 2
PlaceboDRUG

Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)

Group 1Group 2

Eligibility Criteria

Age19 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

pelubiprofen

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 9, 2020

Study Start

September 30, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share