Format

Send to

Choose Destination

See 1 citation found by title matching your search:

J Pain Res. 2019 Sep 23;12:2771-2783. doi: 10.2147/JPR.S217045. eCollection 2019.

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.

Author information

1
Institute of Cardiology and Sports Medicine, Department of Preventive and Rehabilitative Sports Medicine, German Sport University Cologne, Cologne, Germany.
2
Consumer Health Care, Global Medical Head, Sanofi-Aventis, Paris, France.
3
Consumer Health Care, Global Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
4
Consumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.

Abstract

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:

acute back pain; acute neck pain; caffeine; ibuprofen

Conflict of interest statement

Caty Ebel-Bitoun, Robert Lange and Thomas Weiser are employees at Sanofi Aventis. Hans-Georg Predel has received study grants, honoraria for speaking at congresses and consultancy fees from Sanofi-Aventis and personal fees from Reckitt Benckiser, during the conduct of the study. The authors report no other conflicts of interest in this work.

Supplemental Content

Full text links

Icon for Dove Medical Press Icon for PubMed Central
Loading ...
Support Center