NCT03472339 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Derry P, Derry S, Moore RA, McQuay HJ
Single dose oral diclofenac for acute postoperative pain in adults. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004768. doi: 10.1002/14651858.CD004768.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD004768.
Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB
A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10.
Marret E, Kurdi O, Zufferey P, Bonnet F
Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials. Anesthesiology. 2005 Jun;102(6):1249-60.
Pathan SA, Mitra B, Straney LD, Afzal MS, Anjum S, Shukla D, Morley K, Al Hilli SA, Al Rumaihi K, Thomas SH, Cameron PA
Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial. Lancet. 2016 May 14;387(10032):1999-2007. doi: 10.1016/S0140-6736(16)00652-8. Epub 2016 Mar 16.
Turturro MA, Paris PM, Seaberg DC
Intramuscular ketorolac versus oral ibuprofen in acute musculoskeletal pain. Ann Emerg Med. 1995 Aug;26(2):117-20.
Uçar R, Biyik M, Uçar E, Polat I, Çifçi S, Ataseven H, Demir A
Rectal or intramuscular diclofenac reduces the incidence of pancreatitis afterendoscopic retrograde cholangiopancreatography. Turk J Med Sci. 2016 Jun 23;46(4):1059-63. doi: 10.3906/sag-1502-104.

A Randomized Double-blinded Trial Comparing the Clinical Efficacy and Pharmacokinetic Parameters of Oral Diclofenac and Intramuscular Diclofenac in Patients With Acute Limb Injuries

Details for clinical trial NCT03472339

Clinical trial NCT03472339 - References