Chronic Low-back PainPhase 3NCT06516094

Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain

A Phase 3 study testing Celecoxib+Pregabalin+Vitamin B fixed dose, Celecoxib + Vitamin B fixed dose and Pregabalin + Vitamin B fixed dose in people with Chronic Low-back 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 III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and security of the drug combination of Celecoxib / Pregabalin / Vitamin B versus Celecoxib + Vitamin B, versus Pregabalin + Vitamin B in the treatment of chronic low back pain. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Low-back Pain
What is being tested?: Celecoxib+Pregabalin+Vitamin B fixed dose, Celecoxib + Vitamin B fixed dose and Pregabalin + Vitamin B fixed dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 192 participants
Where: 1 siteMexico
Study dates: 11 Apr 2024to 7 Jan 2025
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Agree to participate in the study and give written informed consent
Subjects must have chronic low back pain with a high probability of a significant neuropathic component during 4 years or less (but not less than 3 months)
Patients with chronic low back pain reported as moderate to severe intensity (EVA ≥ 40 mm)
Patients with Neuropathic Pain Questionnaire (DN4) result ≥ 4
Women of childbearing potential under a medically acceptable method of contraception

Who cannot join

Patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start
Patients whose participation in the study may be influenced (employment relationship with the research site or sponsor, inmates, etc.)
At medical discretion, a disease that affects prognosis and prevents outpatient management, for example, but not limited to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness or with scheduled surgical or hospital procedures
History/presence of any disease or condition that, in the opinion of the Investigator, could pose a risk for the patient or confusing the efficacy and safety of the investigational product
Patients in whom the study drug is contraindicated for medical reasons
Patients with allergy or hypersensitivity to the active substance of the study drugs, related products or excipients

Show all 20Show fewer

Pregnant women, women breastfeeding or planning a pregnancy during the conducting the study
Significant history of gastrointestinal diseases (e.g., gastric ulcer, Crohn's disease, Ulcerative Colitis, etc.)
Current treatment with opioids and/or NSAIDs including COX-2 inhibitors (except celecoxib), reported in clinical history in the last 24 hours to the signing of the informed consent
Patients who are receiving monoamineoxidase inhibitors (MAOIs) or who have received them in the course of the 2 weeks prior to signing the informed consent
Patients with a history of alcohol or drug abuse in the last year
Patients with a history of ischemic heart disease, peripheral artery disease, and/or cerebral vascular disease (including patients who have recently undergone coronary revascularization or angioplasty)
Patients with a history of seizures, epileptic status and/or grand mal seizures
History of chronic liver failure Child-Pugh A, B, and/or C
History of acute renal failure (glomerular filtration rate <30 ml/min/1.72 m2)
Patient with a history of chronic pain associated with fibromyalgia, Paget's disease or bone pain induced by metastatic cancer
History of major trauma to the lower back in the past 14 days
Low back pain due to a visceral disorder (e.g., dysmenorrhea, history of endometriosis)
Patients with a history of orthopedic surgery of the lumbar region secondary to chronic low back pain
Patients with symptoms suggestive of COVID-19 infection (fever, cough, dyspnea) and/or contact in the last 14 days with a suspected or positive patient for COVID-19

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: Efficacy and Safety Study of Celecoxib / Pregabalin / Vitamin B Fixed Dose Combination Versus Celecoxib + Vitamin B Versus Pregabalin + Vitamin B in the Management of Chronic Low Back Pain Mixed Component

Read the detailed description

Researchers will compare the fixed-dose combination of Celecoxib/Pregabalin/Vitamin B versus Celecoxib + Vitamin B versus Pregabalin + Vitamin B for chronic low back pain. The adverse events related to the interventions would be registered in each follow up visit.

Participants will:

Be randomized into one of the 3 intervention groups (A,B,C) once a day for 12 weeks
If needed the dose could be escaleted twice a day.
Visit the clinic at weeks 2, 4, 8 and 12 for checkups and follow up

Conditions: Chronic Low-back Pain
Being tested: Celecoxib+Pregabalin+Vitamin B fixed dose, Celecoxib + Vitamin B fixed dose, Pregabalin + Vitamin B fixed dose
Keywords: Low-back pain, Chronic pain, Vitamin B, Pregabalin, Celecoxib
Medical subject headings: Low Back Pain, Chronic Pain

What participants receive

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

Celecoxib+Pregabalin+Vitamin B fixed doseDrug
Also called Cele+Pre+Vit B
One tablet of 200 mg / 150 mg / 100 mg / 50 mg / 0.50 mg + 1 capsule of placebo once a day
Celecoxib + Vitamin B fixed doseDrug
Also called Cele+Vit B
One capsule of 200 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day
Pregabalin + Vitamin B fixed doseDrug
Also called Pre+Vit B
One capsule of 150 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day

Study groups in NCT06516094
Study group	Role	What they receive
Celecoxib+Pregabalin+Vitamin B(thiamine mononitrate/pyridoxone hydrochloride/cyanocobalamin)+Placebo	Experimental	Administered orally, 1 tablet + 1 capsule a day, for 3 months. Receives: Drug: Celecoxib+Pregabalin+Vitamin B fixed dose
Celecoxib + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)	Active comparator	Administered orally, 1 capsule + 1 tablet a day, for 3 months Receives: Drug: Celecoxib + Vitamin B fixed dose
Pregabalin + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)	Active comparator	Administered orally, 1 capsule + 1 tablet a day, for 3 months Receives: Drug: Pregabalin + Vitamin B fixed dose

What is being measured

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

Comparison of the percentage change of Celecoxib / Pregabalin / Vitamin B Combination versus Celecoxib + Vitamin B versus Pregabalin + Vitamin B in the management of chronic low back pain through the visual analog pain scale (VAS).
The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. At the end of the clinical trial the change porcentage will be measured and compared between treatment groups.
Measured: 3 months
Number of participants with treatment-related adverse events through the patient's diary record.
To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher.
Measured: 3 months

Secondary outcomes (17)

To describe the sociodemographic characteristics of the patients included in the study by treatment group
A general description of sex, age, race, weight, height and BMI.
- Body weight: should be obtained on a scale, with the patient without shoes, in a standing position it would be recorded in kilograms.
- Height: must be obtained with a stadimeter, with the patient without shoes, in a standing position, the record will be in meters Height will be measured only at visit 0, and will be taken as a reference for measurement of BMI.
- BMI: calculated with the formula: Weight/height2 and will be recorded in kg/m2.
Weight and height will be combined to report BMI in kg/m^2
Measured: 3 months
Assess the proportion of patients who reported >30% improvement in pain intensity measured through VAS at 12 weeks per treatment group
The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. At the end of the clinical trial the proportion of patiens with an improvement of pain >30% will be reported and compared between treatment groups.
Measured: 3 months
Assess the proportion of patients who reported >50% improvement in pain intensity measured through VAS at 12 weeks per treatment group
The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. At the end of the clinical trial the proportion of patiens with an improvement of pain >50% will be reported and compared between treatment groups.
Measured: 3 months
Assess at what time of follow-up the greatest reduction in pain intensity was achieved, measured through VAS, per treatment group.
The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess time of greatest reduction in pain intensity.
Measured: 3 months
Assess and compare the degree of physical disability due to low back pain, measured through the Oswestry disability questionnaire at 4 and 12 weeks per treatment group.
The Oswestry questionnaire has been designed to give us information as to how the back pain has affected the ability to manage everyday life of patients, it classifies QOL as: no disability, mild disability, moderate disability, severe disability and completely disabled. The disability degree would be compared.
Measured: 3 months
Assess and compare the degree of disability to perform daily activities due to low back pain, reported through Roland-Morris questionnaire at 4 and 12 weeks per group treatment
The Roland-Morris questionnaire has been designed to assess the activities of daily living functional mobility pain. A maximum score of 24 indicates the greatest degree of disability from pain. The disability degree would be compared.
Measured: 3 months
Assess and compare health status through the 5-level, 5-dimensions EuroQol questionnaire (EQ-5D-5L) at 12 weeks from baseline in each group of treatment
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS)The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'.
Measured: 3 months
Report the number of patients that required dose escalation
Dose escalation criteria:
1. Increase in VAS values compared to the previous visit.
2. Use of rescue medication at least in three consecutive occasions.
3. Percentage of adherence to treatment ≥ 80% The researcher will assess the need for dose escalation or not in each visit.
Measured: 3 months
Report the number of patients who require the use of rescue medication during the clinical trial by treatment group.
The rescue medication will be tramadol 50 mg:
- The patient that considers the need for rescue medication must call the doctor, who will be in charge of applying the VAS scale by telephone. If the doctor considers it necessary, the taking of the rescue medication will be indicated.
Measured: 3 months
Report the number of patients who presented therapeutic failure during the study among the treatment groups
Therapeutic failure will be defined by the principal researcher previous medical consult, the following criteria must be present:
- Increase in the parameters of the VAS scale at 12 weeks from baseline
- ≥80% to adherence to treatment
- The consumption of at least 2 doses of the designated group treatment
- The need of use of the rescue medication during 24 consecutive hours
- The absence of comorbidities that could increase the pain (knew traumatism during the clinical trial)
Measured: 3 months
To report the percentage of therapeutic adherence at 12 weeks of intervention by group of treatment.
Therapeutic adherence will be defined by the principal researcher. Adherence to treatment will be defined as a consumption ≥ 80% of the doses that the patient should have ingested at the time of the corresponding evaluation.
Measured: 3 months
Blood concentration of BUN of the patients included in the study by treatment group
A blood sample will be taken in each visit reporting BUN parameters. Comparisons of serum levels between groups will be made.
Measured: 3 months
Blood concentration of glucose of the patients included in the study by treatment group
A blood sample will be taken in each visit reporting glucose parameters. Comparisons of serum levels between groups will be made.
Measured: 3 months
Blood concentration of urea of the patients included in the study by treatment group
A blood sample will be taken in each visit reporting urea parameters. Comparisons of serum levels between groups will be made.
Measured: 3 months
Blood concentration of creatinin of the patients included in the study by treatment group
A blood sample will be taken in each visit reporting creatinin parameters. Comparisons of serum levels between groups will be made.
Measured: 3 months
Blood concentration of Alkaline Phosphatase of the patients included in the study by treatment group
A blood sample will be taken in each visit reporting Alkaline Phosphatase parameters. Comparisons of serum levels between groups will be made.
Measured: 3 months
Blood concentration of total bilirrubin of the patients included in the study by treatment group
A blood sample will be taken in each visit reporting total bilirrubin parameters. Comparisons of serum levels between groups will be made.
Measured: 3 months

Timeline

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

11 Apr 20247 Jan 2025

First posted23 Jul 2024
Study start11 Apr 2024
Primary completion1 Jan 2025
Study completion7 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Chronic Low-back 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: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06516094
Sponsor's protocol ID: SIL-30222-III-22 (1)
Status last verified: Apr 2025
First submitted: 26 Jun 2024
Last updated: 4 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ponce-Monter HA, Ortiz MI, Garza-Hernandez AF, Monroy-Maya R, Soto-Rios M, Carrillo-Alarcon L, Reyes-Garcia G, Fernandez-Martinez E. Effect of diclofenac with B vitamins on the treatment of acute pain originated by lower-limb fracture and surgery. Pain Res Treat. 2012;2012:104782. doi: 10.1155/2012/104782. Epub 2011 Oct 31.
PubMed 22135737
Antonucci R, Zaffanello M, Puxeddu E, Porcella A, Cuzzolin L, Pilloni MD, Fanos V. Use of non-steroidal anti-inflammatory drugs in pregnancy: impact on the fetus and newborn. Curr Drug Metab. 2012 May 1;13(4):474-90. doi: 10.2174/138920012800166607.
PubMed 22299823
Raffaeli W, Arnaudo E. Pain as a disease: an overview. J Pain Res. 2017 Aug 21;10:2003-2008. doi: 10.2147/JPR.S138864. eCollection 2017.
PubMed 28860855
Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
PubMed 22231424
Kongsted A, Kent P, Axen I, Downie AS, Dunn KM. What have we learned from ten years of trajectory research in low back pain? BMC Musculoskelet Disord. 2016 May 21;17:220. doi: 10.1186/s12891-016-1071-2.
PubMed 27209166
Morlion B. Pharmacotherapy of low back pain: targeting nociceptive and neuropathic pain components. Curr Med Res Opin. 2011 Jan;27(1):11-33. doi: 10.1185/03007995.2010.534446. Epub 2010 Nov 18.
PubMed 21083513
Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. Lancet. 2021 Jul 3;398(10294):78-92. doi: 10.1016/S0140-6736(21)00733-9. Epub 2021 Jun 8.
PubMed 34115979
Ho KY, Gwee KA, Cheng YK, Yoon KH, Hee HT, Omar AR. Nonsteroidal anti-inflammatory drugs in chronic pain: implications of new data for clinical practice. J Pain Res. 2018 Sep 20;11:1937-1948. doi: 10.2147/JPR.S168188. eCollection 2018.
PubMed 30288088
Ajmone-Cat MA, Bernardo A, Greco A, Minghetti L. Non-Steroidal Anti-Inflammatory Drugs and Brain Inflammation: Effects on Microglial Functions. Pharmaceuticals (Basel). 2010 Jun 14;3(6):1949-1965. doi: 10.3390/ph3061949.
PubMed 27713336
Wishart DS, Feunang YD, Guo AC, Lo EJ, Marcu A, Grant JR, Sajed T, Johnson D, Li C, Sayeeda Z, Assempour N, Iynkkaran I, Liu Y, Maciejewski A, Gale N, Wilson A, Chin L, Cummings R, Le D, Pon A, Knox C, Wilson M. DrugBank 5.0: a major update to the DrugBank database for 2018. Nucleic Acids Res. 2018 Jan 4;46(D1):D1074-D1082. doi: 10.1093/nar/gkx1037.
PubMed 29126136
Gong L, Thorn CF, Bertagnolli MM, Grosser T, Altman RB, Klein TE. Celecoxib pathways: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2012 Apr;22(4):310-8. doi: 10.1097/FPC.0b013e32834f94cb. No abstract available.
PubMed 22336956

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?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Study of Celecoxib / Pregabalin / Vitamin B Fixed Dose Combination Versus Celecoxib + Vitamin B Versus Pregabalin + Vitamin B in the Management of Chronic Low Back Pain Mixed Component
ClinicalTrials.gov ID: NCT06516094
Acronym / sponsor ID: SIL-30222-III-22 (1)
Conditions: Chronic Low-back Pain
Keywords: Low-back pain, Chronic pain, Vitamin B, Pregabalin, Celecoxib
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
Study start: 11 Apr 2024 (actual)
Primary completion: 1 Jan 2025 (actual)
Study completion: 7 Jan 2025 (actual)
First posted: 23 Jul 2024 (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

Participants will:

Be randomized into one of the 3 intervention groups (A,B,C) once a day for 12 weeks
If needed the dose could be escaleted twice a day.
Visit the clinic at weeks 2, 4, 8 and 12 for checkups and follow up

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Celecoxib+Pregabalin+Vitamin B(thiamine mononitrate/pyridoxone hydrochloride/cyanocobalamin)+Placebo	Experimental	Drug: Celecoxib+Pregabalin+Vitamin B fixed doseAdministered orally, 1 tablet + 1 capsule a day, for 3 months.
Celecoxib + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)	Active comparator	Drug: Celecoxib + Vitamin B fixed doseAdministered orally, 1 capsule + 1 tablet a day, for 3 months
Pregabalin + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)	Active comparator	Drug: Pregabalin + Vitamin B fixed doseAdministered orally, 1 capsule + 1 tablet a day, for 3 months

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Agree to participate in the study and give written informed consent
Subjects must have chronic low back pain with a high probability of a significant neuropathic component during 4 years or less (but not less than 3 months)
Patients with chronic low back pain reported as moderate to severe intensity (EVA ≥ 40 mm)
Patients with Neuropathic Pain Questionnaire (DN4) result ≥ 4
Women of childbearing potential under a medically acceptable method of contraception

Key exclusion criteria (20 listed)

Patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start
Patients whose participation in the study may be influenced (employment relationship with the research site or sponsor, inmates, etc.)
At medical discretion, a disease that affects prognosis and prevents outpatient management, for example, but not limited to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness or with scheduled surgical or hospital procedures
History/presence of any disease or condition that, in the opinion of the Investigator, could pose a risk for the patient or confusing the efficacy and safety of the investigational product
Patients in whom the study drug is contraindicated for medical reasons

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
Celecoxib+Pregabalin+Vitamin B fixed doseAlso: Cele+Pre+Vit BOne tablet of 200 mg / 150 mg / 100 mg / 50 mg / 0.50 mg + 1 capsule of placebo once a day	Drug	Celecoxib+Pregabalin+Vitamin B(thiamine mononitrate/pyridoxone hydrochloride/cyanocobalamin)+Placebo
Celecoxib + Vitamin B fixed doseAlso: Cele+Vit BOne capsule of 200 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day	Drug	Celecoxib + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)
Pregabalin + Vitamin B fixed doseAlso: Pre+Vit BOne capsule of 150 mg + 1 tablet of 100 mg / 50 mg / 0.50 mg once a day	Drug	Pregabalin + Vitamin B (thiamine mononitrate/ pyridoxone hydrochloride/ cyanocobalamin)

Primary outcome

Comparison of the percentage change of Celecoxib / Pregabalin / Vitamin B Combination versus Celecoxib + Vitamin B versus Pregabalin + Vitamin B in the management of chronic low back pain through the visual analog pain scale (VAS).
Time frame: 3 months
The visual analog pain scale (VAS) is a straight line in which one end signifies absence of pain and the other means the worst pain imaginable. The researcher will apply the VAS scale to each patient at each visit to assess pain intensity. At the end of the clinical trial the change porcentage will be measured and compared between treatment groups.
Number of participants with treatment-related adverse events through the patient's diary record.
Time frame: 3 months
To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher.

17 secondary outcomes

To describe the sociodemographic characteristics of the patients included in the study by treatment group
Time frame: 3 months
Assess the proportion of patients who reported >30% improvement in pain intensity measured through VAS at 12 weeks per treatment group
Time frame: 3 months
Assess the proportion of patients who reported >50% improvement in pain intensity measured through VAS at 12 weeks per treatment group
Time frame: 3 months
Assess at what time of follow-up the greatest reduction in pain intensity was achieved, measured through VAS, per treatment group.
Time frame: 3 months
Assess and compare the degree of physical disability due to low back pain, measured through the Oswestry disability questionnaire at 4 and 12 weeks per treatment group.
Time frame: 3 months
Assess and compare the degree of disability to perform daily activities due to low back pain, reported through Roland-Morris questionnaire at 4 and 12 weeks per group treatment
Time frame: 3 months
Assess and compare health status through the 5-level, 5-dimensions EuroQol questionnaire (EQ-5D-5L) at 12 weeks from baseline in each group of treatment
Time frame: 3 months
Report the number of patients that required dose escalation
Time frame: 3 months
Report the number of patients who require the use of rescue medication during the clinical trial by treatment group.
Time frame: 3 months
Report the number of patients who presented therapeutic failure during the study among the treatment groups
Time frame: 3 months
To report the percentage of therapeutic adherence at 12 weeks of intervention by group of treatment.
Time frame: 3 months
Blood concentration of BUN of the patients included in the study by treatment group
Time frame: 3 months
Blood concentration of glucose of the patients included in the study by treatment group
Time frame: 3 months
Blood concentration of urea of the patients included in the study by treatment group
Time frame: 3 months
Blood concentration of creatinin of the patients included in the study by treatment group
Time frame: 3 months
Blood concentration of Alkaline Phosphatase of the patients included in the study by treatment group
Time frame: 3 months
Blood concentration of total bilirrubin of the patients included in the study by treatment group
Time frame: 3 months

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 4 Apr 2025.
Background: PubMed 22135737Ponce-Monter HA, Ortiz MI, Garza-Hernandez AF, Monroy-Maya R, Soto-Rios M, Carrillo-Alarcon L, Reyes-Garcia G, Fernandez-Martinez E. Effect of diclofenac with B vitamins on the treatment of acute pain originated by lower-limb fracture and surgery. Pain Res Treat. 2012;2012:104782. doi: 10.1155/2012/104782. Epub 2011 Oct 31.
Background: PubMed 22299823Antonucci R, Zaffanello M, Puxeddu E, Porcella A, Cuzzolin L, Pilloni MD, Fanos V. Use of non-steroidal anti-inflammatory drugs in pregnancy: impact on the fetus and newborn. Curr Drug Metab. 2012 May 1;13(4):474-90. doi: 10.2174/138920012800166607.
Results publication: PubMed 28860855Raffaeli W, Arnaudo E. Pain as a disease: an overview. J Pain Res. 2017 Aug 21;10:2003-2008. doi: 10.2147/JPR.S138864. eCollection 2017.
Results publication: PubMed 22231424Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
Results publication: PubMed 27209166Kongsted A, Kent P, Axen I, Downie AS, Dunn KM. What have we learned from ten years of trajectory research in low back pain? BMC Musculoskelet Disord. 2016 May 21;17:220. doi: 10.1186/s12891-016-1071-2.
Results publication: PubMed 21083513Morlion B. Pharmacotherapy of low back pain: targeting nociceptive and neuropathic pain components. Curr Med Res Opin. 2011 Jan;27(1):11-33. doi: 10.1185/03007995.2010.534446. Epub 2010 Nov 18.
Results publication: PubMed 34115979Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. Lancet. 2021 Jul 3;398(10294):78-92. doi: 10.1016/S0140-6736(21)00733-9. Epub 2021 Jun 8.
Results publication: PubMed 30288088Ho KY, Gwee KA, Cheng YK, Yoon KH, Hee HT, Omar AR. Nonsteroidal anti-inflammatory drugs in chronic pain: implications of new data for clinical practice. J Pain Res. 2018 Sep 20;11:1937-1948. doi: 10.2147/JPR.S168188. eCollection 2018.
Results publication: PubMed 27713336Ajmone-Cat MA, Bernardo A, Greco A, Minghetti L. Non-Steroidal Anti-Inflammatory Drugs and Brain Inflammation: Effects on Microglial Functions. Pharmaceuticals (Basel). 2010 Jun 14;3(6):1949-1965. doi: 10.3390/ph3061949.
Results publication: PubMed 29126136Wishart DS, Feunang YD, Guo AC, Lo EJ, Marcu A, Grant JR, Sajed T, Johnson D, Li C, Sayeeda Z, Assempour N, Iynkkaran I, Liu Y, Maciejewski A, Gale N, Wilson A, Chin L, Cummings R, Le D, Pon A, Knox C, Wilson M. DrugBank 5.0: a major update to the DrugBank database for 2018. Nucleic Acids Res. 2018 Jan 4;46(D1):D1074-D1082. doi: 10.1093/nar/gkx1037.
Results publication: PubMed 22336956Gong L, Thorn CF, Bertagnolli MM, Grosser T, Altman RB, Klein TE. Celecoxib pathways: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2012 Apr;22(4):310-8. doi: 10.1097/FPC.0b013e32834f94cb. No abstract available.
Low back painLink provided by the sponsor.
Non-steroidal anti-inflammatory drugs: an overviewLink provided by the sponsor.
Nonsteroidal anti-inflammatory drugs in chronic pain: implications of new data for clinical practiceLink provided by the sponsor.
National Center for Biotechnology Information (2022). PubChem Compound Summary for CID 2662, CelecoxibLink provided by the sponsor.
National Center for Biotechnology InformationLink provided by the sponsor.
National Center for Biotechnology Information (2022). PubChem Compound Summary for CID 1130, ThiamineLink 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.

Juan L Torres-Méndez principal investigator

Clínica de Ozonoterapia RGH, A.C.

Raul Coca-Nuñez principal investigator

CICMEX

Adelfia Urenda-Quezada principal investigator

Imacen 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?

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 5 inclusion and 20 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 4 Apr 2025. 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?

Comparison of the percentage change of Celecoxib / Pregabalin / Vitamin B Combination versus Celecoxib + Vitamin B versus Pregabalin + Vitamin B in the management of chronic low back pain through the visual analog pain scale (VAS). (time frame: 3 months). The study lists 2 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 NCT06516094, which also lists 11 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 4 Apr 2025.