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

NCT ID: NCT04541134

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-08-30

Brief Summary

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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

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Detailed Description

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Conditions

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Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

Study Groups

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Group 1

Group Type OTHER

Pelubiprofen 45mg

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Group 2

Group Type OTHER

Pelubiprofen 45mg

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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Pelubiprofen 45mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DW9801-303

Identifier Type: -

Identifier Source: org_study_id

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