DysmenorrheaPhase 4NCT02373514
IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea
A Phase 4 study testing Paracetamol and Dexketoprofen in people with Dysmenorrhea, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Patients presented with dysmenorrhea composed the study population. One gram paracetamol and 50 mg dexketoprofen in 100 ml saline with a rapid infusion were compared in ceasing dysmenorrhea in emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Paracetamol and Dexketoprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Mar 2015
- Phase
- Phase 4
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with dysmenorrhea
- Patients over 18 years old
Who cannot join
- denied to give inform consent
- Renal or liver failure
- Allergy to the study drugs
- Receiving pain killer within the last 6 hours.
- Physical examination findings consistent with peritoneal irritation
- Pregnancy or patients with lactation
- Drug addiction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli
Mustafa Serinken, MD, 0090 505 2991497, aserinken@hotmail.com
About this study
Official title: Intravenous Paracetamol Versus Intravenous Dexketoprofen in Patients Presented With Dysmenorrhea in Emergency Department
Patients presented with dysmenorrhea composed the study population. One gram paracetamol and 50 mg dexketoprofen in 100 ml saline with a rapid infusion were compared in ceasing dysmenorrhea in emergency department.
Read the detailed description
Patients over 18 years old who presented with dysmenorrhea composed the study population. Patients received pain killer within the last six hours, physical findings consistent with peritoneal irritation, allergy to the study drugs, renal or liver failure, drug addiction, pregnancy or woman with lactation and denied to give inform consent were the exclusion criteria. The pain of the study patients are measured with visual analogue scale at baseline, 15th and 30th minutes. At the end of the 30 minutes, rescue drug need is also recorded.
- Conditions
- Dysmenorrhea
- Being tested
- Paracetamol, Dexketoprofen
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Perfalgan
1 gr paracetamol in 100 ml saline with rapid infusion
DexketoprofenDrug
Also called Arveles
50 mg dexketoprofen in 100 ml saline with rapid infusion
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | Intravenous 1 gm paracetamol in 100 ml saline with rapid infusion Receives: Drug: Paracetamol |
| Dexketoprofen | Active comparator | Intravenous 50 mg dexketoprofen in 100 ml saline with rapid infusion Receives: Drug: Dexketoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Change in visual analogue scale at 15th minutes from baseline
Measured: 15 minutes
Visual Analogue Scale
Change in visual analogue scale at 30th minutes from baseline
Measured: 30 minutes
Secondary outcomes (2)
Rescue drug need
Measured: 30 minutes
Adverse effects
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenker Eken, Akdeniz University
- Investigators
- Mustafa Serinken, MD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373514
- Sponsor's protocol ID
- 57051259-020/70177
- Status last verified
- Feb 2015
- First submitted
- 23 Feb 2015
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Paracetamol Versus Intravenous Dexketoprofen in Patients Presented With Dysmenorrhea in Emergency Department
- ClinicalTrials.gov ID
- NCT02373514
- Acronym / sponsor ID
- 57051259-020/70177
- Conditions
- Dysmenorrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 27 Feb 2015 (estimated)
- 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.
Patients presented with dysmenorrhea composed the study population. One gram paracetamol and 50 mg dexketoprofen in 100 ml saline with a rapid infusion were compared in ceasing dysmenorrhea in emergency department.
Detailed description
Patients over 18 years old who presented with dysmenorrhea composed the study population. Patients received pain killer within the last six hours, physical findings consistent with peritoneal irritation, allergy to the study drugs, renal or liver failure, drug addiction, pregnancy or woman with lactation and denied to give inform consent were the exclusion criteria. The pain of the study patients are measured with visual analogue scale at baseline, 15th and 30th minutes. At the end of the 30 minutes, rescue drug need is also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: ParacetamolIntravenous 1 gm paracetamol in 100 ml saline with rapid infusion |
| Dexketoprofen | Active comparator | Drug: DexketoprofenIntravenous 50 mg dexketoprofen in 100 ml saline with rapid infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with dysmenorrhea
- Patients over 18 years old
Key exclusion criteria (7 listed)
- denied to give inform consent
- Renal or liver failure
- Allergy to the study drugs
- Receiving pain killer within the last 6 hours.
- Physical examination findings consistent with peritoneal irritation
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 |
|---|---|---|
| ParacetamolAlso: Perfalgan1 gr paracetamol in 100 ml saline with rapid infusion | Drug | Paracetamol |
| DexketoprofenAlso: Arveles50 mg dexketoprofen in 100 ml saline with rapid infusion | Drug | Dexketoprofen |
Primary outcome
Visual Analogue Scale
Time frame: 15 minutes
Change in visual analogue scale at 15th minutes from baseline
Visual Analogue Scale
Time frame: 30 minutes
Change in visual analogue scale at 30th minutes from baseline
2 secondary outcomes
Rescue drug need
Time frame: 30 minutes
Adverse effects
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
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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.
Mustafa Serinken, MD principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol and Dexketoprofen in people with Dysmenorrhea, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Cenker Eken, Medical Doctor (0090 532 1593948, cenkereken@akdeniz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 15 minutes). 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 27 Feb 2015.