A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea

NCT02253446 | Completed Phase 4 DMC

• 1 other identifier: MDhayri2014
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Primary Dysmenorrhea

Keywords

Dysmenorrhea; Piroxicam; Diclofenac Sodium; Emergency department

Outcome Measures

Primary Outcomes (1)

• Compare decrease of dysmenorrhea VAS (visual analog scale) score between the two groups. - (First group Piroxicam and Second Diclofenac Sodium)

  Change from Baseline in dysmenorrhea pain VAS scores at 60 minutes.

Study Arms (2)

Piroksikam

EXPERIMENTAL

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

Drug: Piroxicam

Diclofenac Sodium

EXPERIMENTAL

Second Group: Diclofenac sodium 75mg (Miyadren drug-ampoule -Yavuz Istanbul) intramuscularly (IM) was given 200 patients.

Drug: Diclofenac Sodium

Interventions

Piroxicam DRUG

20 mg of piroxicam (Feldene ampoule-Pfizer-France) intramuscularly (IM) was given 200 patients,

Also known as: Feldene 20 mg/1 mL Solution injectable IM

Piroksikam

Diclofenac Sodium DRUG

Second Group: Diclofenac sodium 75mg (Miyadren ampoule-bulb-Yavuz Istanbul) intramuscularly (IM) was given 200 patients.

Also known as: DICLOMEC (Solution injectable IM), DIKLORON (Solution injectable IM ), MIYADREN (Solution injectable IM ), VOLTAREN (Solution injectable IM )

Diclofenac Sodium

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• had Primary Dysmenorrhea
• VAS (visual analog scale) score \>5.

You may not qualify if:

• Patients with severe liver, kidney and heart failure
• After the use of aspirin or other nonsteroidal antiinflammatory drugs, asthma, nasal polyps, angioedema and urticaria to be seen
• To have active peptic ulcer bleeding or perforation
• Have a history of upper gastrointestinal disease
• The presence of Phenylketonuria disease
• To be Pregnancy and breast-feeding
• To be Asthma patients
• Have received analgesics in the last 4 hours
• Patients of childbearing age who are not using a birth control method.
• The patient who using digoxin, lithium, furosemide and other diuretics, acetylsalicylic acid and anticoagulant coumadin
• Physical examination and suspected acute abdomen.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale Universty

Denizli, Denizli, 20000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea; Emergencies

Interventions

Piroxicam; Diclofenac

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Mehpare camlibel, MD

  pamukkale universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 1, 2014
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

TU (1)