A randomized, placebo- and active-controlled, multi-country, multi-center parallel group trial to evaluate the efficacy and safety of a fixed-dose combination of 400 mg ibuprofen and 100 mg caffeine compared with ibuprofen 400 mg and placebo in patients with acute lower back or neck pain
Authors Predel HG, Ebel-Bitoun C, Lange R, Weiser T
Received 24 May 2019
Accepted for publication 17 August 2019
Published 23 September 2019 Volume 2019:12 Pages 2771—2783
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr E Alfonso Romero-Sandoval
Hans-Georg Predel,1 Caty Ebel-Bitoun,2 Robert Lange,3 Thomas Weiser4
1Institute of Cardiology and Sports Medicine, Department of Preventive and Rehabilitative Sports Medicine, German Sport University Cologne, Cologne, Germany; 2Consumer Health Care, Global Medical Head, Sanofi-Aventis, Paris, France; 3Consumer Health Care, Global Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany; 4Consumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany
Correspondence: Thomas Weiser
Consumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt am Main 65926 Germany
Tel +49 693 053 9966
Background: Ibuprofen is a well-established analgesic for acute pain symptoms. In several acute pain models, caffeine has demonstrated an analgesic adjuvant effect. This randomized trial (NCT03003000) was designed to compare the efficacy of a fixed-dose combination of ibuprofen and caffeine with ibuprofen or placebo for the treatment of acute lower back/neck pain.
Methods: Patients with acute lower back/neck pain resulting in pain on movement (POM) ≥5 on a 10-point numerical rating scale were randomized 2:2:1 to receive orally, three times daily for 6 days, 400 mg ibuprofen+100 mg caffeine, 400 mg ibuprofen or placebo, respectively. The primary endpoint was change in POMWP (POM triggering highest pain score at baseline [worst procedure]) between baseline and the morning of day 2. Key secondary endpoints included POMWP area under curve (AUC) between baseline and the morning of day 4 (POMWPAUC72h) and day 6 (POMWPAUC120h).
Results: In total, 635 patients were randomized (256 ibuprofen + caffeine: 253 ibuprofen: 126 placebo). Active treatments exhibited similar reductions in POMWP, with an adjusted mean reduction of 1.998 (standard error [SE]: 0.1042) between baseline and day 2 for ibuprofen, 1.869 (SE: 0.1030) for ibuprofen + caffeine and 1.712 (SE: 0.1422) for placebo. Similar results were observed for POMWPAUC72h and POMWPAUC120h. Safety and tolerability was as expected.
Conclusion: A decrease in lower back/neck pain, indicated by reduced POMWP, was shown in all active treatment arms; however, treatment effects were small versus placebo. Ibuprofen plus caffeine was not superior to ibuprofen alone or placebo for the treatment of acute lower back/neck pain in this setting.
Keywords: ibuprofen, caffeine, acute back pain, acute neck pain
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