Evidence map›Paper›PMID 30136102›Full record

Trial reportEuropean journal of clinical pharmacology2018

A pharmacokinetic drug-drug interaction study between pregabalin and tramadol in healthy volunteers.

Soyoung Lee, Yun Kim, Janice Ji Sung Lee, Guangjin Im, Joo-Youn Cho, Jae-Yong Chung, Seonghae Yoon

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05324059 (Confirmatory Study of Efficacy and Safety of the Pregabalin/Tramadol Combination Versus Pregabalin in the Management of Acute Pain of Neuropathic Origin.), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.0field-weighted citation impact, top 15% 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.

NCT05324059 phase3completednot on this mapstarted 2022, after this paper: background citation

Confirmatory Study of Efficacy and Safety of the Pregabalin/Tramadol Combination Versus Pregabalin in the Management of Acute Pain of Neuropathic Origin.

TypeinterventionalSponsorLaboratorios Silanes S.A. de C.V.Ran2022 to 2023Enrolled110ConditionsNeuropathic PainArmsPregabalin 75mg/ Tramadol 50 mg, Pregabalin 75mg
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. 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

7 authors at 3 institutions in 1 country.

Soyoung LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul, Republic of Korea.
Yun KimDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul, Republic of Korea.
Janice Ji Sung LeeSamChunDang Pharm.Co.,Ltd., Seoul, Republic of Korea.
Guangjin ImSamChunDang Pharm.Co.,Ltd., Seoul, Republic of Korea.
Joo-Youn ChoDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul, Republic of Korea.
Jae-Yong ChungDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul, Republic of Korea.
Seonghae YoonClinical Trials Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. nymph223@snu.ac.kr.
Seoul National University · KRSam Chun Dang Pharm (South Korea) · KRSeoul National University Bundang Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCombination therapy of pregabalin and tramadol is used to treat chronic neuropathic pain; however, the pharmacokinetic (PK) interactions of these drugs has not been studied. This study aimed to evaluate PK interactions between pregabalin and tramadol and the safety of combination therapy.

methodsA randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence cross-over study was conducted in healthy subjects. All subjects received the following three treatments for 4 days in each period: pregabalin 150 mg twice daily; tramadol extended-release (ER) 200 mg in the morning, and 100 mg in the evening; and co-administration of pregabalin 150 mg and tramadol ER 200 mg in the morning, and pregabalin 150 mg and tramadol ER 100 mg in the evening.

resultsA total of 21 subjects completed the study with no clinically significant safety issues. For pregabalin, the geometric mean ratio (GMR) (90% CI; confidence interval) of combination therapy to monotherapy for maximum concentration at steady state (C

conclusionsThere were no significant drug interactions between pregabalin and tramadol, considering that all of the 90% CI of PK measures were within the conventional bioequivalence range. Both drugs were well tolerated when administered concomitantly.

Indexed as

AdultAnalgesicsAnalgesics, OpioidArea Under CurveCross-Over StudiesDelayed-Action PreparationsDrug InteractionsElectrocardiographyHealthy VolunteersHumansMalePregabalinTramadolYoung AdultAnalgesicsAnalgesics, OpioidDelayed-Action PreparationsPregabalinTramadolDrug-drug interactionsPharmacokineticsPregabalinTramadol

Identifiers

PMID30136102
OpenAlexW2888233297

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.