<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02253446</url>
  </required_header>
  <id_info>
    <org_study_id>MDhayri2014</org_study_id>
    <nct_id>NCT02253446</nct_id>
  </id_info>
  <brief_title>A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea</brief_title>
  <official_title>A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea:A Double-Blind, Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Currently, nonsteroidal antiinflammatory drugs are widely used by emergency physicians&#xD;
           in Turkey for the treatment of patients with Primary Dysmenorrhea.&#xD;
&#xD;
        -  The objective of the study is compare intramuscular Diclofenac sodium and piroxicam's&#xD;
           pain reduction dysmenorrhea in emergency department (ED) adults.&#xD;
&#xD;
        -  The investigators second aim was to compare recurrent dysmenorrhea pain within 24 hours&#xD;
           after discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  this is the randomized double blinded clinical trial to compare the efficacy of these&#xD;
           two drugs in this clinical setting.&#xD;
&#xD;
        -  A randomized clinical trial was conducted in the ED of Pamukkale University Medical&#xD;
           Faculty Hospital&#xD;
&#xD;
        -  Study personnel (emergency physicians and nurses) were trained before the study.&#xD;
&#xD;
        -  When intramuscular drugs (Piroxicam, Diclofenac sodium) was being recommended, an&#xD;
           eligibility checklist was completed by the attending physician.&#xD;
&#xD;
        -  If there were no exclusion criteria, written informed consent was obtained and baseline&#xD;
           information, including initial Dysmenorrhea pain severity ratings with VAS were&#xD;
           recorded.&#xD;
&#xD;
        -  The need for identification and enrollment of participants by staff with conflicting&#xD;
           work pressures resulted in recruitment of a convenience sample of patients.&#xD;
&#xD;
        -  All patients eligible for the study were randomized to one of two groups:&#xD;
&#xD;
        -  First Group: 20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM)&#xD;
           was given 200 patients,&#xD;
&#xD;
        -  Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul)&#xD;
           intramuscularly (IM) was given 200 patients which determined to be applied as a group.&#xD;
&#xD;
        -  Drug packs prepared in 5 ml syringes were numbered by an independent nurse, who not&#xD;
           involved in the study.&#xD;
&#xD;
        -  Drugs were prepared according to the computer-generated random number sequence to assign&#xD;
           treatment allocations&#xD;
&#xD;
        -  The allocation list was kept by the emergency nurse. Patients received the piroxicam,&#xD;
           diclofenac sodium medication schemes according to their random allocations.&#xD;
&#xD;
        -  After enrollment and recording of baseline information, the next numbered study drug&#xD;
           pack was obtained, and administered as a intramuscular.&#xD;
&#xD;
        -  Randomization was achieved by using computer software to generate random numbers. During&#xD;
           the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an&#xD;
           automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and&#xD;
           rhythms)&#xD;
&#xD;
        -  One researcher blinded to patient allocation observed the whole procedure and recorded&#xD;
           the Dysmenorrhea pain scores.&#xD;
&#xD;
        -  Patients in both groups received two types of medication in a similar manner, thus&#xD;
           ensuring double blinding.&#xD;
&#xD;
        -  Dysmenorrhea pain scores were recorded at 0, 15, 30, 45 and 60 min on a VAS of 1 to 10&#xD;
&#xD;
        -  Rescue medication (100 mg of tramadol hydrochloride) was given intramuscular to patients&#xD;
           if pain VAS scores ≥ 5 in forty five minutes after study drug administration.&#xD;
&#xD;
        -  All other medications required during the study also were recorded.&#xD;
&#xD;
        -  During the study, pulse rate, systolic blood pressure, diastolic blood pressure,&#xD;
           respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30,&#xD;
           and 60 min.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare decrease of dysmenorrhea VAS (visual analog scale) score between the two groups. - (First group Piroxicam and Second Diclofenac Sodium)</measure>
    <time_frame>Change from Baseline in dysmenorrhea pain VAS scores at 60 minutes.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Primary Dysmenorrhea</condition>
  <arm_group>
    <arm_group_label>Piroksikam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM) was given 200 patients,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac Sodium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul) intramuscularly (IM) was given 200 patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Piroxicam</intervention_name>
    <description>20 mg of piroxicam (Feldene ampoule-Pfizer-France) intramuscularly (IM) was given 200 patients,</description>
    <arm_group_label>Piroksikam</arm_group_label>
    <other_name>Feldene 20 mg/1 mL Solution injectable IM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac Sodium</intervention_name>
    <description>Second Group: Diclofenac sodium 75mg (Miyadren ampoule-bulb-Yavuz Istanbul) intramuscularly (IM) was given 200 patients.</description>
    <arm_group_label>Diclofenac Sodium</arm_group_label>
    <other_name>DICLOMEC (Solution injectable IM)</other_name>
    <other_name>DIKLORON (Solution injectable IM )</other_name>
    <other_name>MIYADREN (Solution injectable IM )</other_name>
    <other_name>VOLTAREN (Solution injectable IM )</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients were eligible for inclusion if they were aged 18 years or older, 45 years or&#xD;
             younger&#xD;
&#xD;
          -  had Primary Dysmenorrhea&#xD;
&#xD;
          -  VAS (visual analog scale) score &gt;5.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe liver, kidney and heart failure&#xD;
&#xD;
          -  After the use of aspirin or other nonsteroidal antiinflammatory drugs, asthma, nasal&#xD;
             polyps, angioedema and urticaria to be seen&#xD;
&#xD;
          -  To have active peptic ulcer bleeding or perforation&#xD;
&#xD;
          -  Have a history of upper gastrointestinal disease&#xD;
&#xD;
          -  The presence of Phenylketonuria disease&#xD;
&#xD;
          -  To be Pregnancy and breast-feeding&#xD;
&#xD;
          -  To be Asthma patients&#xD;
&#xD;
          -  Have received analgesics in the last 4 hours&#xD;
&#xD;
          -  Patients of childbearing age who are not using a birth control method.&#xD;
&#xD;
          -  The patient who using digoxin, lithium, furosemide and other diuretics,&#xD;
             acetylsalicylic acid and anticoagulant coumadin&#xD;
&#xD;
          -  Physical examination and suspected acute abdomen.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehpare camlibel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>pamukkale universty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pamukkale Universty</name>
      <address>
        <city>Denizli</city>
        <zip>20000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 27, 2014</last_update_submitted>
  <last_update_submitted_qc>September 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Bulent Erdur</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Dysmenorrhea</keyword>
  <keyword>Piroxicam</keyword>
  <keyword>Diclofenac Sodium</keyword>
  <keyword>Emergency department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
    <mesh_term>Piroxicam</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02253446
org study id: MDhayri2014
nct id: NCT02253446
lead sponsor: 
has dmc: Yes
-  Currently, nonsteroidal antiinflammatory drugs are widely used by emergency physicians
           in Turkey for the treatment of patients with Primary Dysmenorrhea.

        -  The objective of the study is compare intramuscular Diclofenac sodium and piroxicam's
           pain reduction dysmenorrhea in emergency department (ED) adults.

        -  The investigators second aim was to compare recurrent dysmenorrhea pain within 24 hours
           after discharge.
-  this is the randomized double blinded clinical trial to compare the efficacy of these
           two drugs in this clinical setting.

        -  A randomized clinical trial was conducted in the ED of Pamukkale University Medical
           Faculty Hospital

        -  Study personnel (emergency physicians and nurses) were trained before the study.

        -  When intramuscular drugs (Piroxicam, Diclofenac sodium) was being recommended, an
           eligibility checklist was completed by the attending physician.

        -  If there were no exclusion criteria, written informed consent was obtained and baseline
           information, including initial Dysmenorrhea pain severity ratings with VAS were
           recorded.

        -  The need for identification and enrollment of participants by staff with conflicting
           work pressures resulted in recruitment of a convenience sample of patients.

        -  All patients eligible for the study were randomized to one of two groups:

        -  First Group: 20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM)
           was given 200 patients,

        -  Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul)
           intramuscularly (IM) was given 200 patients which determined to be applied as a group.

        -  Drug packs prepared in 5 ml syringes were numbered by an independent nurse, who not
           involved in the study.

        -  Drugs were prepared according to the computer-generated random number sequence to assign
           treatment allocations

        -  The allocation list was kept by the emergency nurse. Patients received the piroxicam,
           diclofenac sodium medication schemes according to their random allocations.

        -  After enrollment and recording of baseline information, the next numbered study drug
           pack was obtained, and administered as a intramuscular.

        -  Randomization was achieved by using computer software to generate random numbers. During
           the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an
           automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and
           rhythms)

        -  One researcher blinded to patient allocation observed the whole procedure and recorded
           the Dysmenorrhea pain scores.

        -  Patients in both groups received two types of medication in a similar manner, thus
           ensuring double blinding.

        -  Dysmenorrhea pain scores were recorded at 0, 15, 30, 45 and 60 min on a VAS of 1 to 10

        -  Rescue medication (100 mg of tramadol hydrochloride) was given intramuscular to patients
           if pain VAS scores ≥ 5 in forty five minutes after study drug administration.

        -  All other medications required during the study also were recorded.

        -  During the study, pulse rate, systolic blood pressure, diastolic blood pressure,
           respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30,
           and 60 min.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Compare decrease of dysmenorrhea VAS (visual analog scale) score between the two groups. - (First group Piroxicam and Second Diclofenac Sodium)
time frame: Change from Baseline in dysmenorrhea pain VAS scores at 60 minutes.
arm group label: Piroksikam
arm group type: Experimental
description: 20 mg of piroxicam (feldene ampoule -Pfizer-France) intramuscularly (IM) was given 200 patients,
arm group label: Diclofenac Sodium
arm group type: Experimental
description: Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul) intramuscularly (IM) was given 200 patients.
intervention type: Drug
intervention name: Piroxicam
description: 20 mg of piroxicam (Feldene ampoule-Pfizer-France) intramuscularly (IM) was given 200 patients,
arm group label: Piroksikam
other name: Feldene 20 mg/1 mL Solution injectable IM
intervention type: Drug
intervention name: Diclofenac Sodium
description: Second Group: Diclofenac sodium 75mg (Miyadren ampoule-bulb-Yavuz Istanbul) intramuscularly (IM) was given 200 patients.
arm group label: Diclofenac Sodium
other name: DICLOMEC (Solution injectable IM)
other name: DIKLORON (Solution injectable IM )
other name: MIYADREN (Solution injectable IM )
other name: VOLTAREN (Solution injectable IM )
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Mehpare camlibel, MD
role: Principal Investigator
affiliation: pamukkale universty
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Bulent Erdur
investigator title: professor
mesh term: Dysmenorrhea
mesh term: Diclofenac
mesh term: Piroxicam
mesh term: Pharmaceutical Solutions