Primary DysmenorrheaPhase 3NCT04541134
Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea
A Phase 3 study testing Pelubiprofen 45mg in people with Primary Dysmenorrhea, run by Daewon Pharmaceutical Co., Ltd..
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 44 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Pelubiprofen 45mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2020to 30 Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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
- Conditions
- Primary Dysmenorrhea
- Being tested
- Pelubiprofen 45mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelubiprofen 45mgDrug
Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)
PlaceboDrug
Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Not described Receives: Drug: Pelubiprofen 45mg; Drug: Placebo |
| Group 2 | Other | Not described Receives: Drug: Pelubiprofen 45mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TOTPAR-8
Time weighted sum of total pain relief
Measured: Day 1
SPID-8
Sum of pain intensity difference
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start30 Sep 2020 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541134
- Sponsor's protocol ID
- DW9801-303
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04541134
- Acronym / sponsor ID
- DW9801-303
- Conditions
- Primary Dysmenorrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: Pelubiprofen 45mg, Drug: Placebo |
| Group 2 | Other | Drug: Pelubiprofen 45mg, Drug: Placebo |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelubiprofen 45mgPelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn) | Drug | Group 1, Group 2 |
| PlaceboPlacebo1 tab for moderate or severe menstrual pain, bid for 3days(prn) | Drug | Group 1, Group 2 |
Primary outcome
TOTPAR-8
Time frame: Day 1
Time weighted sum of total pain relief
SPID-8
Time frame: Day 1
Sum of pain intensity difference
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pelubiprofen 45mg in people with Primary Dysmenorrhea, run by Daewon Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TOTPAR-8 (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.