Evidence map›Paper›PMID 38922520›Full record

ArticlePain and therapy2024

Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE).

Giustino Varrassi, Magdi Hanna, Stefano Coaccioli, Paolo Fabrizzi, Simone Baldini, Ivan Kruljac, Carles Brotons, Serge Perrot

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pain and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05170841 (Randomized, Double-blind, Placebo-controlled, Parallel Arm Group Study Evaluating Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride on Moderate to Severe Acute Pain in Patients With Acute Low Back Pain), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05170841 phase4completednot on this map

Randomized, Double-blind, Placebo-controlled, Parallel Arm Group Study Evaluating Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride on Moderate to Severe Acute Pain in Patients With Acute Low Back Pain

TypeinterventionalSponsorMenarini International Operations Luxembourg SARan2020 to 2022Enrolled538ConditionsLow Back PainArmsDexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg, Tramadol Hydrochloride 100 mg, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Giustino VarrassiPaolo Procacci Foundation, Via Tacito 7, 00193, Rome, Italy. giuvarr@gmail.com.ORCID http://orcid.org/0000-0002-3822-2923
Magdi HannaAnalgesics and Pain Research (APR) Ltd, Beckenham, UK.
Stefano CoaccioliEuropean League Against Pain, Zurich, Switzerland.
Paolo FabrizziA. Menarini Industrie Farmaceutiche Riunite S.r.l., Florence, Italy.
Simone BaldiniA. Menarini Industrie Farmaceutiche Riunite S.r.l., Florence, Italy.
Ivan KruljacPoliklinika SOLMED d.o.o., Preradovićeva ulica 20, 10000, Zagreb, Croatia.
Carles BrotonsSardenya Primary Health Care Center, Institut de Recerca Sant Pau (IR SANT PAU), Barcelona, Spain.
Serge PerrotPain Center, INSERM U987, Hôpital Cochin, University of Paris, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDexketoprofen/tramadol 25/75 mg (DKP/TRAM) is a fixed-dose combination of a cyclooxygenase inhibitor and opioid receptor agonist. To better understand the efficacy and safety of DKP/TRAM in the treatment of moderate to severe acute lower back pain (LBP) with or without radiculopathy, we carried out a large explorative phase IV international, multicenter, prospective, randomized, double-blind, parallel group, placebo-controlled study (DANTE).

methodsA total of 538 patients with or without a history of LBP and experiencing acute LPB of moderate to severe intensity [Numerical Rating Scale-Pain Intensity (NRS-PI) score > 5] were randomized 4:4:1:1 to DKP/TRAM 25/75 mg every 8 h (n = 211), tramadol (TRAM) 100 mg (n = 207), placebo-matched DKP/TRAM (n = 59), or placebo-matched TRAM (n = 61).

resultsThe proportion of patients achieving the primary endpoint, defined as the time to first achieve NRS-PI score < 4 or pain intensity reduction ≥ 30% from drug intake up to 8 h after the first dose, was higher in the DKP/TRAM arm than in the placebo group, but the difference was not statistically significant (46.1% vs. 42.6%, respectively; hazard ratio 1.11; 95% confidence interval 0.775, 1.595; p = 0.566). DKP/TRAM achieved superiority over TRAM in total pain relief at 4, 6, and 8 h (p < 0.05). Conversely, in relation to the secondary endpoints, a significantly greater reduction in NRS-PI score was seen with DKP/TRAM versus placebo starting from 1 h, and this reduction remained numerically lower throughout 8 h. Summed pain intensity difference values were also significantly lower at 4, 6, and 8 h with DKP/TRAM compared to TRAM (p < 0.05). Overall, DKP/TRAM was well tolerated.

conclusionAlthough the primary endpoint was not met, secondary efficacy analyses suggest the superiority of DKP/TRAM over placebo and TRAM alone in terms of total pain relief. DKP/TRAM can be considered to be an effective and safe option for the treatment of moderate to severe acute LBP. DANTE STUDY REGISTRATION: EudraCT number: 2019-003656-37; ClinicalTrials.gov Identifier: NCT05170841.

Indexed as

Acute low back painClinical trialDexketoprofen trometamolFixed-dose combinationTramadol hydrochloride

Identifiers

PMID38922520
PMCPMC11255173

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.