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Clinical Trial Comparing Intravenous and Oral Diclofenac and Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT03472339
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Isma Qureshi, Hamad Medical Corporation

Brief Summary:

NSAIDs are commonly used in the management of acute pain; Diclofenac is one from the same class. It is an amino phenyl acetic acid derivative which inhibits prostaglandin biosynthesis to produce analgesic, antipyretic and anti-inflammatory effect. The drug efficacy and safety in acute pain management has been proved by several studies like in renal colic, post and pre-operative pain management, migraines etc. It's also known to have an opioid-sparing effect. Mode of administration is one of the important factors to consider in a busy emergency room. Perception about the route of administration differs among patients. As believed,injectable have rapid onset, easier to titrate, and patients respond better to them as they consider them stronger than oral medication. Number of trials has compared oral and parenteral NSAIDs. Most found no benefit to the parenteral route. Considering the limitations of the previously done studies like small sample size, heterogeneity in the group of patients enrolled, improper blinding and comparing of two different drugs from the same class. Therefore, aim of the study is to conduct a Double blind randomized clinical trial to assess the clinical efficacy and pharmacokinetic parameters of oral diclofenac compared to intramuscular diclofenac in patients with acute limb injury.

In this two group double blind randomized clinical trial, the clinical efficacy and pharmacokinetic parameters among the two groups will be assessed. Eligible patients visiting to HGH-ED, age (above 18 years) with acute limb injury, having moderate to severe pain (defined as pain score of >=4 on Numerical rating scale) will be recruited. With the use of computer generated block randomization, subjects will be allocated to one of the two treatment groups in the ratio of 1:1. Each group will receive either (intramuscular diclofenac / oral placebo) or (oral diclofenac / intramuscular placebo). Among the 300 subjects enrolled for the study, further stratified randomization will be done in order to enroll 20 patients for pharmacokinetic study within the subjects.High-performance liquid chromatography, method will be used for the determination of drug concentration in human plasma, for detailed pharmacokinetics. The pain score will be assessed by using the validated pain scale i.e. Numerical rating scale (NRS). The participants, clinicians and investigators will be masked to treatment assigned and the results will be analyzed by the intention to treat analysis among the two group treatment.


Condition or disease Intervention/treatment Phase
Pain Management Limb Injury Drug: Diclofenac Sodium Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: A computer generated block randomization sequence will be generated and stored with sequential coding known to the clinical pharmacist only. Within the randomization another stratified randomized sequence will be generated, for the patients to be enrolled for the PK study. Among the 300 trial packets prepared for the study, 20 packets will contain one additional code that will indicate the subject to be enrolled in the PK study.
Primary Purpose: Treatment
Official Title: A Randomized Double-blinded Trial Comparing the Clinical Efficacy and Pharmacokinetic Parameters of Oral Diclofenac and Intramuscular Diclofenac in Patients With Acute Limb Injuries
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : April 15, 2018
Estimated Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group A
diclofenac sodium75 mg, intravenously, once
Drug: Diclofenac Sodium
Group A-Intramuscular diclofenac sodium+oral placebo Group B-Oral diclofenac sodium+ intramuscular placebo
Active Comparator: Group B
diclofenac sodium 100 mg, orally, once
Drug: Diclofenac Sodium
Group A-Intramuscular diclofenac sodium+oral placebo Group B-Oral diclofenac sodium+ intramuscular placebo



Primary Outcome Measures :
  1. Difference in proportion of patients achieving 50% pain reduction [ Time Frame: 30 mins ]
    The primary outcome is defined as the proportion of patients achieving pain reduction by 50% at 30 minutes following analgesia administration.

  2. the mean difference in plasma concentration for two drugs [ Time Frame: 60 mins ]
    Cmax - Peak plasma concentration and Time curve


Secondary Outcome Measures :
  1. proportion of patients achieving pain reduction of >=2 Numerical Rating Scale( which is a numeric scale where respondent selects a whole number from 0 to 10, where 0 means no pain and 10 means worst pain) from the initial score [ Time Frame: at 30 mins ]
    to assess proportion of patients who could achieve minimal significant pain reduction

  2. Rescue analgesia [ Time Frame: after 30 mins ]
    proportion of patients requiring a rescue analgesia after 30 min in each group

  3. Adverse events [ Time Frame: 2 hours ]
    the number of adverse events in each group



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Eligible patients are those adults (age at least 18years), presenting to HGH-ED with complaints of acute limb injury, initially evaluated by the physician.

Inclusion criteria:

  1. Healthy volunteers
  2. Adult patients above 18-65 years of age.
  3. Patients with soft tissue injury/ cut wounds
  4. Pain score more than or equal to 4 on NRS.
  5. Patients weight more than or equal to 50kgs.
  6. If treating physician approves patient participation in the study.
  7. Not on any medication.

Exclusion criteria:

  1. Received any analgesic within last 12 hours, on the day of visit to ED.
  2. Patients with fractures
  3. Allergic to diclofenac.
  4. Cardio-vascular disease, renal impairment, stroke or any other co-morbidity / chronic illness.
  5. Pregnancy / Nursing
  6. Peptic ulcers
  7. Bleeding disorders
  8. liver disease
  9. Bronchial asthma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472339


Locations
Qatar
Isma Qureshi Recruiting
Doha, Qatar, 3050
Contact: Isma Qureshi    44390985    iqureshi@hamad.qa   
Principal Investigator: Isma Qureshi, MBBS         
Sponsors and Collaborators
Hamad Medical Corporation

Publications:

Responsible Party: Dr. Isma Qureshi, Academic Research Associate, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT03472339     History of Changes
Other Study ID Numbers: 16413/16
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. Isma Qureshi, Hamad Medical Corporation:
Acute limb injury, Diclofenac, pain management

Additional relevant MeSH terms:
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action