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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
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea

Eligibility Criteria

19 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    September 1, 2020
    Last Updated
    September 1, 2020
    Sponsor
    Daewon Pharmaceutical Co., Ltd.
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    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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