Trial · NCT06516094
Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain
NCT06516094, Phase 3, Completed, Laboratorios Silanes S.A. de C.V.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain. Trials, record NCT06516094. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06516094
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain
- NCT number
- NCT06516094
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 192 participants, actual
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Conditions
- Chronic Low-back Pain
- Interventions
- Celecoxib+Pregabalin+Vitamin B fixed dose, Celecoxib + Vitamin B fixed dose, Pregabalin + Vitamin B fixed dose
- First posted
- 2024-07-23
- Last updated
- 2025-04-04
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). | 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. |
| Primary | Number of participants with treatment-related adverse events through the patient's diary record. | 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. |
| Secondary | To describe the sociodemographic characteristics of the patients included in the study by treatment group | 3 months | 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 |
| Secondary | Assess the proportion of patients who reported >30% improvement in pain intensity measured through VAS at 12 weeks per treatment group | 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 proportion of patiens with an improvement of pain \>30% will be reported and compared between treatment groups. |
| Secondary | Assess the proportion of patients who reported >50% improvement in pain intensity measured through VAS at 12 weeks per treatment group | 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 proportion of patiens with an improvement of pain \>50% will be reported and compared between treatment groups. |
| Secondary | Assess at what time of follow-up the greatest reduction in pain intensity was achieved, measured through VAS, per treatment group. | 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 time of greatest reduction in pain intensity. |
| Secondary | 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. | 3 months | 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. |
| Secondary | 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 | 3 months | 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. |
| Secondary | 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 | 3 months | 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'. |
| Secondary | Report the number of patients that required dose escalation | 3 months | 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06516094
GET https://conductscience.org/api/trials/v1/NCT06516094/registered