Neuropathic PainPhase 3LOBUXALIIINCT05324059

Efficacy and Safety of Pregabalin/Tramadol Combination Versus Pregabalin in Acute Pain of Neuropathic Origin

A Phase 3 study testing Pregabalin 75mg/ Tramadol 50 mg and Pregabalin 75mg in people with Neuropathic Pain, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Phase IIIb confirmatory study of efficacy and safety, longitudinal, multicenter, randomized, double-blind study of the combination Pregabalin/Tramadol versus Pregabalin in the management of acute pain of neuropathic origin. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Neuropathic Pain
What is being tested?: Pregabalin 75mg/ Tramadol 50 mg and Pregabalin 75mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteMexico
Study dates: 11 Jul 2022to 25 Apr 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Any gender.
That the subject agrees to participate in the study and give its informed consent in writing.
Age >18 years and ≤65 years of age at the start of the study.
Neuropathic Pain Questionnaire (DN4) ≥ 4.
Patients with proven tolerability (absence of moderate-serious adverse events) to pregabalin, defined by consumption of pregabalin 50 mg/day for 3 days.
Women of childbearing age who have an acceptable method of contraception (eg barrier, oral hormonal, injectable, subdermal).

Who cannot join

Contraindication and known hypersensitivity to the use of pregabalin and/or tramadol.
The patient is participating in another clinical study involving an investigational treatment or participated in any in the previous 4 weeks.
In the medical opinion, a disease that affects the prognosis and prevents outpatient management, for example, but not limited or restricted to: terminal cancer, heart failure, obstruction gastrointestinal including paralytic ileus, suspected surgical abdomen, respiratory failure with scheduled surgical or hospital procedures.
Positive pregnancy test, women who are pregnant, nursing or planning a pregnancy during the conduct of the study.
Patients with a diagnosis of respiratory diseases: status asthmaticus, asthma, chronic obstructive pulmonary disease (COPD), cor pulmonale, acute respiratory depression, hypercapnia.
Patients who are receiving monoamine oxidase inhibitors (MAOIs) or who have received within the last 2 weeks.

Show all 14Show fewer

Patients with a history of seizure disorders, epileptic status, and grand mal seizures.
Patients with a history of severe depression of the central nervous system due to consumption of opiates.
History of acute intoxications with hypnotics, opioid analgesics and psychotropics.
History of alcohol or drug abuse (including opiates) in the last year according to DSM-V.
Patients with a history of severe head trauma and/or brain edema.
History/presence of any disease or condition which, in the opinion of the Investigator, could pose a risk to the patient or confound the efficacy and safety results of the study.
Patients with symptoms suggestive of active COVID-19 infection (i.e., fever, cough, dyspnea) and/or contact in the last 14 days with a suspected or positive patient for COVID-19.
Patients whose participation in the study may be influenced (employment relationship with the center investigator or sponsor, inmates, etc.).

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Laboratorio Silanes, S.A. de C.V.
Mexico City, 11000

Other trials in Mexico

About this study

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

Read the detailed description

Study to evaluate the efficacy and safety of the fixed-dose combination of Pregabalin/Tramadol versus Pregabalin in the management of acute pain of neuropathic origin. Patients who meet the inclusion criteria of the protocol and start treatment with the combination Pregabalin / Tramadol (75 mg / 50 mg) or Pregabalin 75 mg will be included. To evaluate the proportion of subjects who reported a success rate in the reduction of pain by 50%, the percentage of change in the pain intensity reported through the Visual Analog Pain Scale (VAS) will be calculated. This percentage will be categorized and the proportion of patients per treatment group will quantify. Changes in pain intensity during the intervention will be evaluated with the fixed-dose combination of Pregabalin/Tramadol (75 mg / 50 mg) or Pregabalin 75 mg, comparing the average difference in pain reported through VAS at days 1, 3, 5, 7, 10, 13 and 15 with respect to their baseline measurement. The mean change in reported neuropathic pain intensity across the DN4 questionnaire will also be evaluated, comparing its measurement on day 3, 10 and 15 with respect to the baseline, in each treatment group.

At visit 1 (day 3) the need for dose escalation will be evaluated (Pregabalin/Tramadol (150 mg / 50 mg) or pregabalin (150 mg)) in both treatment groups, continuing with its follow-up in the evaluation of the intensity of pain reported by EVA and DN4. The proportion of subjects who started on the dose of Pregabalin / Tramadol (75 mg / 50 mg) or Pregabalin 75 mg, those that required adjustment of dose to treatment (Pregabalin / Tramadol (150 mg / 50 mg) or Pregabalin (75 mg)), as well as the proportion of patients who suspended the treatment.

The percentage of adherence to the intervention by treatment group will be reported.

The proportion of adverse events presented during the conduct of the study will be evaluated, regardless of the dose administered, to all the subjects who have received at least one dose of the investigational drug Which will be reported be reported through frequencies and percentages and classified according to frequency, gravity, severity (intensity) and the causality of the clinical manifestation.

Conditions: Neuropathic Pain
Being tested: Pregabalin 75mg/ Tramadol 50 mg, Pregabalin 75mg
Keywords: Acute pain, Neuropathic, Pregabalin, Tramadol
Medical subject headings: Neuralgia, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pregabalin 75mg/ Tramadol 50 mgDrug
Also called LOBUXAL
Pharmaceutical Form: Tablet Dosage: 75 mg / 50 mg Administration way: oral
Pregabalin 75mgDrug
Also called Pregabalin
Pharmaceutical Form: Capsule Dosage: 75 mg Administration way: oral

Study groups in NCT05324059
Study group	Role	What they receive
Group A: Pregabalin/Tramadol	Experimental	Fixed dose combination tablet of 75 mg Pregabalin and 50 mg of Tramadol, orally, every 12 hours. Receives: Drug: Pregabalin 75mg/ Tramadol 50 mg
Group B: Pregabalin	Active comparator	Monotherapy with 75 mg of Pregabalin, orally, every 12 hours. Receives: Drug: Pregabalin 75mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of subjects with a success rate of >50% in pain reduction
Evaluate the proportion of subjects who reported a success rate of >50% in pain reduction at completion of the intervention, measure by the VAS (Visual Analog Scale) per treatment group. In a straight 10 centimeter line in which one end means no pain and the other end means the worst pain imaginable, the participants mark the amount of pain feeling at that moment.
Measured: 15 days
Mean change in pain intensity by VAS (Visual Analog Scale)
Evaluate the mean change in pain intensity reported on days 1, 3, 5, 7, 10, 13, and 15 with respect to its baseline measurement, reported through the VAS (Visual Analog Scale) per treatment group. In a straight 10 centimeter line in which one end means no pain and the other end means the worst pain imaginable, the participants mark the amount of pain feeling at that moment.
Measured: Baseline,1,3,5,7,10, 13 and 15 days
Mean change in pain intensity by DN4 questionnaire
Evaluate the mean change in pain intensity reported on days 3, 10 and 15 with respect to its baseline measurement according to the DN4 Questionnaire by treatment group.
Measured: Baseline, 3, 10 and 15 days
Proportion of subjects requiring dose escalation
Evaluate the proportion of subjects who required dose escalation (from Pregabalin/Tramadol 75mg/50 to 150 mg/ 50 mg or Pregabalin 75mg to 150 mg, as appropriate) during the intervention, by treatment group.
Measured: Day 3
Frequency of adverse events
Compare the frequency of adverse events presented during the study between the treatment groups.
Measured: 15 days
Intensity of adverse events.
Compare the intensity of adverse events presented by treatment group.
Measured: 15 days

Secondary outcomes (1)

Adherence percentage
Report the percentage of adherence to the intervention by treatment group, using the count of tablets returned to the research site
Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 202225 Apr 2023

First posted12 Apr 2022
Study start11 Jul 2022
Primary completion18 Apr 2023
Study completion25 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Neuropathic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05324059
Sponsor's protocol ID: SIL-30901-III-21 (2)
Acronym: LOBUXALIII
Status last verified: Jun 2023
First submitted: 4 Apr 2022
Last updated: 15 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Taylor RS. Epidemiology of refractory neuropathic pain. Pain Pract. 2006 Mar;6(1):22-6. doi: 10.1111/j.1533-2500.2006.00054.x.
PubMed 17309705
Torrance N, Smith BH, Bennett MI, Lee AJ. The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey. J Pain. 2006 Apr;7(4):281-9. doi: 10.1016/j.jpain.2005.11.008.
PubMed 16618472
Matthiesen T, Wohrmann T, Coogan TP, Uragg H. The experimental toxicology of tramadol: an overview. Toxicol Lett. 1998 Mar 16;95(1):63-71. doi: 10.1016/s0378-4274(98)00023-x.
PubMed 9650647
Randinitis EJ, Posvar EL, Alvey CW, Sedman AJ, Cook JA, Bockbrader HN. Pharmacokinetics of pregabalin in subjects with various degrees of renal function. J Clin Pharmacol. 2003 Mar;43(3):277-83. doi: 10.1177/0091270003251119.
PubMed 12638396
Ardakani YH, Rouini MR. Pharmacokinetics of tramadol and its three main metabolites in healthy male and female volunteers. Biopharm Drug Dispos. 2007 Dec;28(9):527-34. doi: 10.1002/bdd.584.
PubMed 17891748
de Moraes NV, Lauretti GR, Lanchote VL. Effects of type 1 and type 2 diabetes on the pharmacokinetics of tramadol enantiomers in patients with neuropathic pain phenotyped as cytochrome P450 2D6 extensive metabolizers. J Pharm Pharmacol. 2014 Sep;66(9):1222-30. doi: 10.1111/jphp.12255. Epub 2014 Apr 10.
PubMed 24717054
Bockbrader HN, Radulovic LL, Posvar EL, Strand JC, Alvey CW, Busch JA, Randinitis EJ, Corrigan BW, Haig GM, Boyd RA, Wesche DL. Clinical pharmacokinetics of pregabalin in healthy volunteers. J Clin Pharmacol. 2010 Aug;50(8):941-50. doi: 10.1177/0091270009352087. Epub 2010 Feb 10.
PubMed 20147618
Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4.
PubMed 25078976
Lee S, Kim Y, Lee JJS, Im G, Cho JY, Chung JY, Yoon S. A pharmacokinetic drug-drug interaction study between pregabalin and tramadol in healthy volunteers. Eur J Clin Pharmacol. 2018 Dec;74(12):1605-1613. doi: 10.1007/s00228-018-2543-0. Epub 2018 Aug 22.
PubMed 30136102
Vandenbossche J, Richards H, Solanki B, Van Peer A. Single- and multiple-dose pharmacokinetic studies of tramadol immediate-release tablets in children and adolescents. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):184-92. doi: 10.1002/cpdd.169. Epub 2014 Dec 22.
PubMed 27140798
Vandenbossche J, Van Peer A, Richards H. Single-Dose Pharmacokinetic Study of Tramadol Extended-Release Tablets in Children and Adolescents. Clin Pharmacol Drug Dev. 2016 Sep;5(5):343-53. doi: 10.1002/cpdd.266. Epub 2016 Jun 12.
PubMed 27138295
Dou Z, Jiang Z, Zhong J. Efficacy and safety of pregabalin in patients with neuropathic cancer pain undergoing morphine therapy. Asia Pac J Clin Oncol. 2017 Apr;13(2):e57-e64. doi: 10.1111/ajco.12311. Epub 2014 Dec 22.
PubMed 25530068
Harati Y, Gooch C, Swenson M, Edelman S, Greene D, Raskin P, Donofrio P, Cornblath D, Sachdeo R, Siu CO, Kamin M. Double-blind randomized trial of tramadol for the treatment of the pain of diabetic neuropathy. Neurology. 1998 Jun;50(6):1842-6. doi: 10.1212/wnl.50.6.1842.
PubMed 9633738
Wang SL, Wang H, Nie HY, Bu G, Shen XD, Wang H. The efficacy of pregabalin for acute pain control in herpetic neuralgia patients: A meta-analysis. Medicine (Baltimore). 2017 Dec;96(51):e9167. doi: 10.1097/MD.0000000000009167.
PubMed 29390451
Markman J, Resnick M, Greenberg S, Katz N, Yang R, Scavone J, Whalen E, Gregorian G, Parsons B, Knapp L. Efficacy of pregabalin in post-traumatic peripheral neuropathic pain: a randomized, double-blind, placebo-controlled phase 3 trial. J Neurol. 2018 Dec;265(12):2815-2824. doi: 10.1007/s00415-018-9063-9. Epub 2018 Sep 21.
PubMed 30242745

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neuropathic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Confirmatory Study of Efficacy and Safety of the Pregabalin/Tramadol Combination Versus Pregabalin in the Management of Acute Pain of Neuropathic Origin.
ClinicalTrials.gov ID: NCT05324059
Acronym / sponsor ID: LOBUXALIII / SIL-30901-III-21 (2)
Conditions: Neuropathic Pain
Keywords: Acute pain, Neuropathic, Pregabalin, Tramadol
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
Study start: 11 Jul 2022 (actual)
Primary completion: 18 Apr 2023 (actual)
Study completion: 25 Apr 2023 (actual)
First posted: 12 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The percentage of adherence to the intervention by treatment group will be reported.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group A: Pregabalin/Tramadol	Experimental	Drug: Pregabalin 75mg/ Tramadol 50 mgFixed dose combination tablet of 75 mg Pregabalin and 50 mg of Tramadol, orally, every 12 hours.
Group B: Pregabalin	Active comparator	Drug: Pregabalin 75mgMonotherapy with 75 mg of Pregabalin, orally, every 12 hours.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Any gender.
That the subject agrees to participate in the study and give its informed consent in writing.
Age >18 years and ≤65 years of age at the start of the study.
Neuropathic Pain Questionnaire (DN4) ≥ 4.
Patients with proven tolerability (absence of moderate-serious adverse events) to pregabalin, defined by consumption of pregabalin 50 mg/day for 3 days.

Key exclusion criteria (14 listed)

Contraindication and known hypersensitivity to the use of pregabalin and/or tramadol.
The patient is participating in another clinical study involving an investigational treatment or participated in any in the previous 4 weeks.
In the medical opinion, a disease that affects the prognosis and prevents outpatient management, for example, but not limited or restricted to: terminal cancer, heart failure, obstruction gastrointestinal including paralytic ileus, suspected surgical abdomen, respiratory failure with scheduled surgical or hospital procedures.
Positive pregnancy test, women who are pregnant, nursing or planning a pregnancy during the conduct of the study.
Patients with a diagnosis of respiratory diseases: status asthmaticus, asthma, chronic obstructive pulmonary disease (COPD), cor pulmonale, acute respiratory depression, hypercapnia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pregabalin 75mg/ Tramadol 50 mgAlso: LOBUXALPharmaceutical Form: Tablet Dosage: 75 mg / 50 mg Administration way: oral	Drug	Group A: Pregabalin/Tramadol
Pregabalin 75mgAlso: PregabalinPharmaceutical Form: Capsule Dosage: 75 mg Administration way: oral	Drug	Group B: Pregabalin

Primary outcome

Proportion of subjects with a success rate of >50% in pain reduction
Time frame: 15 days
Evaluate the proportion of subjects who reported a success rate of >50% in pain reduction at completion of the intervention, measure by the VAS (Visual Analog Scale) per treatment group. In a straight 10 centimeter line in which one end means no pain and the other end means the worst pain imaginable, the participants mark the amount of pain feeling at that moment.
Mean change in pain intensity by VAS (Visual Analog Scale)
Time frame: Baseline,1,3,5,7,10, 13 and 15 days
Evaluate the mean change in pain intensity reported on days 1, 3, 5, 7, 10, 13, and 15 with respect to its baseline measurement, reported through the VAS (Visual Analog Scale) per treatment group. In a straight 10 centimeter line in which one end means no pain and the other end means the worst pain imaginable, the participants mark the amount of pain feeling at that moment.
Mean change in pain intensity by DN4 questionnaire
Time frame: Baseline, 3, 10 and 15 days
Evaluate the mean change in pain intensity reported on days 3, 10 and 15 with respect to its baseline measurement according to the DN4 Questionnaire by treatment group.
Proportion of subjects requiring dose escalation
Time frame: Day 3
Evaluate the proportion of subjects who required dose escalation (from Pregabalin/Tramadol 75mg/50 to 150 mg/ 50 mg or Pregabalin 75mg to 150 mg, as appropriate) during the intervention, by treatment group.
Frequency of adverse events
Time frame: 15 days
Compare the frequency of adverse events presented during the study between the treatment groups.
Intensity of adverse events.
Time frame: 15 days
Compare the intensity of adverse events presented by treatment group.

1 secondary outcome

Adherence percentage
Time frame: 15 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Background: PubMed 17309705Taylor RS. Epidemiology of refractory neuropathic pain. Pain Pract. 2006 Mar;6(1):22-6. doi: 10.1111/j.1533-2500.2006.00054.x.
Background: PubMed 16618472Torrance N, Smith BH, Bennett MI, Lee AJ. The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey. J Pain. 2006 Apr;7(4):281-9. doi: 10.1016/j.jpain.2005.11.008.
Background: PubMed 9650647Matthiesen T, Wohrmann T, Coogan TP, Uragg H. The experimental toxicology of tramadol: an overview. Toxicol Lett. 1998 Mar 16;95(1):63-71. doi: 10.1016/s0378-4274(98)00023-x.
Background: PubMed 12638396Randinitis EJ, Posvar EL, Alvey CW, Sedman AJ, Cook JA, Bockbrader HN. Pharmacokinetics of pregabalin in subjects with various degrees of renal function. J Clin Pharmacol. 2003 Mar;43(3):277-83. doi: 10.1177/0091270003251119.
Background: PubMed 17891748Ardakani YH, Rouini MR. Pharmacokinetics of tramadol and its three main metabolites in healthy male and female volunteers. Biopharm Drug Dispos. 2007 Dec;28(9):527-34. doi: 10.1002/bdd.584.
Background: PubMed 24717054de Moraes NV, Lauretti GR, Lanchote VL. Effects of type 1 and type 2 diabetes on the pharmacokinetics of tramadol enantiomers in patients with neuropathic pain phenotyped as cytochrome P450 2D6 extensive metabolizers. J Pharm Pharmacol. 2014 Sep;66(9):1222-30. doi: 10.1111/jphp.12255. Epub 2014 Apr 10.
Background: PubMed 20147618Bockbrader HN, Radulovic LL, Posvar EL, Strand JC, Alvey CW, Busch JA, Randinitis EJ, Corrigan BW, Haig GM, Boyd RA, Wesche DL. Clinical pharmacokinetics of pregabalin in healthy volunteers. J Clin Pharmacol. 2010 Aug;50(8):941-50. doi: 10.1177/0091270009352087. Epub 2010 Feb 10.
Background: PubMed 25078976Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4.
Background: PubMed 30136102Lee S, Kim Y, Lee JJS, Im G, Cho JY, Chung JY, Yoon S. A pharmacokinetic drug-drug interaction study between pregabalin and tramadol in healthy volunteers. Eur J Clin Pharmacol. 2018 Dec;74(12):1605-1613. doi: 10.1007/s00228-018-2543-0. Epub 2018 Aug 22.
Background: PubMed 27140798Vandenbossche J, Richards H, Solanki B, Van Peer A. Single- and multiple-dose pharmacokinetic studies of tramadol immediate-release tablets in children and adolescents. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):184-92. doi: 10.1002/cpdd.169. Epub 2014 Dec 22.
Background: PubMed 27138295Vandenbossche J, Van Peer A, Richards H. Single-Dose Pharmacokinetic Study of Tramadol Extended-Release Tablets in Children and Adolescents. Clin Pharmacol Drug Dev. 2016 Sep;5(5):343-53. doi: 10.1002/cpdd.266. Epub 2016 Jun 12.
Background: PubMed 25530068Dou Z, Jiang Z, Zhong J. Efficacy and safety of pregabalin in patients with neuropathic cancer pain undergoing morphine therapy. Asia Pac J Clin Oncol. 2017 Apr;13(2):e57-e64. doi: 10.1111/ajco.12311. Epub 2014 Dec 22.
Rincon Carvajal AM, Olaya Osorio CA, Martínez Rojas S, Ibata Bernal L. Recommendations based on in evidence for the management of neuropathic pain in Primary Health Care (Review of the literature). Rev Soc Esp Pain \[Internet\]. 2018 \[cited 2021 Dec 29\];Link provided by the sponsor.
Health Secretary. Official Mexican STANDARD NOM-220-SSA1-2016, Installation and operation of the pharmacovigilanceLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rodrigo Suárez Otero, M.D principal investigator

Independent consultant

Isabel E Rucker, M.D principal investigator

Clinical Research Institute

Luis R Partida, M.D principal investigator

Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pregabalin 75mg/ Tramadol 50 mg and Pregabalin 75mg in people with Neuropathic Pain, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with a success rate of >50% in pain reduction (time frame: 15 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05324059, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.