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

September 1, 2020 updated by: Daewon Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
Drug: Pelubiprofen 45mg
Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)
Drug: Placebo
Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)
Other: Group 2
Drug: Pelubiprofen 45mg
Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)
Drug: Placebo
Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TOTPAR-8
Time Frame: Day 1
Time weighted sum of total pain relief
Day 1
SPID-8
Time Frame: Day 1
Sum of pain intensity difference
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 30, 2020

Primary Completion (Anticipated)

August 30, 2021

Study Completion (Anticipated)

August 30, 2021

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW9801-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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