Evidence map›Paper›PMID 28644196›Full record

Trial reportPain2017

Cebranopadol, a novel first-in-class analgesic drug candidate: first experience in patients with chronic low back pain in a randomized clinical trial.

Annette Christoph, Marie-Henriette Eerdekens, Maurits Kok, Gisela Volkers, Rainer Freynhagen

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Pain, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 4 pooled it
6.5field-weighted citation impact, top 3% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 4 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Impact of treatment duration on the effectiveness of opioid analgesia: a systematic review and meta-analysis.The British journal of general practice : the journal of the Royal College of General Practitioners · 2026
    Pooled it
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  5. Trial
  6. Article
  7. Review
  8. Article
  9. Review
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  11. Article
  12. Pain Medication in Chronic Low Back Pain.Life (Basel, Switzerland) · 2025
    Review
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  14. Review
  15. Article
  16. Cebranopadol for the Treatment of Chronic Pain.Current pain and headache reports · 2023
    Review
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  19. Article
  20. Review
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

5 authors at 2 institutions in 1 country.

Annette ChristophGrünenthal GmbH, Grünenthal Innovation, Aachen, Germany.
Marie-Henriette EerdekensGrünenthal GmbH, Grünenthal Innovation, Aachen, Germany.
Maurits KokGrünenthal GmbH, Grünenthal Innovation, Aachen, Germany.
Gisela VolkersGrünenthal GmbH, Grünenthal Innovation, Aachen, Germany.
Rainer FreynhagenDepartment of Anaesthesiology, Pain Center Lake Starnberg, Benedictus Hospital, Tutzing, Germany.
Grünenthal Group (Germany) · DEKlinikum rechts der Isar · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chronic low back pain (LBP) is a common condition, usually with the involvement of nociceptive and neuropathic pain components, high economic burden and impact on quality of life. Cebranopadol is a potent, first-in-class drug candidate with a novel mechanistic approach, combining nociceptin/orphanin FQ peptide and opioid peptide receptor agonism. We conducted the first phase II, randomized, double-blind, placebo- and active-controlled trial, evaluating the analgesic efficacy, safety, and tolerability of cebranopadol in patients with moderate-to-severe chronic LBP with and without neuropathic pain component. Patients were treated for 14 weeks with cebranopadol 200, 400, or 600 μg once daily, tapentadol 200 mg twice daily, or placebo. The primary efficacy endpoints were the change from baseline pain to the weekly average 24-hour pain during the entire 12 weeks and during week 12 of the maintenance phase. Cebranopadol demonstrated analgesic efficacy, with statistically significant and clinically relevant improvements over placebo for all doses as did tapentadol. The responder analysis (≥30% or ≥50% pain reduction) confirmed these results. Cebranopadol and tapentadol displayed beneficial effects on sleep and functionality. Cebranopadol treatment was safe, with higher doses leading to higher treatment discontinuations because of treatment-emergent adverse events occurring mostly during titration. Those patients reaching the target doses had an acceptable tolerability profile. The incidence rate of most frequently reported treatment-emergent adverse events during maintenance phase was ≤10%. Although further optimizing the titration scheme to the optimal dose for individual patients is essential, cebranopadol is a new drug candidate with a novel mechanistic approach for potential chronic LBP treatment.

Indexed as

AdultAgedAnalgesicsChronic PainDose-Response Relationship, DrugDouble-Blind MethodEuropeFemaleFollow-Up StudiesHumansIndolesLow Back PainMaleMiddle AgedPain MeasurementRetrospective Studies6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amineAnalgesicsIndolesSpiro Compounds

Identifiers

PMID28644196
PMCPMC5761752
OpenAlexW2722711213

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.