Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pelubiprofen 45mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1
Group 2
Arm Description
Outcomes
Primary Outcome Measures
TOTPAR-8
Time weighted sum of total pain relief
SPID-8
Sum of pain intensity difference
Secondary Outcome Measures
Full Information
NCT ID
NCT04541134
First Posted
September 1, 2020
Last Updated
September 1, 2020
Sponsor
Daewon Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04541134
Brief Title
Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2020 (Anticipated)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Title
Group 2
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Pelubiprofen 45mg
Intervention Description
Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)
Primary Outcome Measure Information:
Title
TOTPAR-8
Description
Time weighted sum of total pain relief
Time Frame
Day 1
Title
SPID-8
Description
Sum of pain intensity difference
Time Frame
Day 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea
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