The Effect of Pregabalin and Etoricoxib on Pain Alone Versus in Combination

NCT06401499 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: WM&DCR/R&D(ERB)/2024/92
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the effects of pregabalin in reducing pain intensity and improving functional disability in patients with chronic low back pain of neuropathic origin when used in combination with Etoricoxib. Hypothesis Pregabalin-etoricoxib combination is more effective than etoricoxib monotherapy in reducing pain and improving functional status in patients with chronic low back pain. Null Hypothesis: There is no significant difference between pregabalin-etoricoxib combination and etoricoxib monotherapy in reducing pain and improving functional status in patients with chronic low back pain. Study Design: Comparative clinical study Setting: Watim General Hospital Duration of study: 18 months after ethical approval Sample Size: a previous study (8), was used to calculate the sample size, Using the WHO sample size calculator, a sample size of 140 patients (70 in each group) was determined with a 5% level of significance and 95% power of test. Sampling Technique: non-probability convenience sampling. Sample selection Inclusion criteria:

• Participants within age 20-65 years
• Both male and non-pregnant non-lactating female patients will be included in the study
• Patients experiencing CLBP symptoms from last 6 months
• No experience of previous low back surgery Exclusion Criteria:
• Patients with the history of antidepressant, opioid, and benzodiazepine medications
• Patients with the history of CYP1A2 inhibitors usage
• Patients already taking pregabalin
• Patients with the history of suicidal ideation, severe depression, anxiety disorder psychosis, and cognitive impairment Data collection Participants will be divided into two study groups. Group A (n=70) participant will receive 60mg Etoricoxib once daily along with a placebo and Group B (n=70) participants will also receive etoricoxib 60mg once daily(15) along with a placebo for 4 weeks. At the start of week 5 the group B will start taking Pregabalin 75mg along with Etoricoxib 60mg once daily for next 4 weeks, while, group A will continue same treatment as before. At Weeks 0 and 4 and 8 of the study, participants will be evaluated. Liver enzyme levels will be measured both at the beginning and end of the trial. The pain will be measured using numeric rating scale (NRS). CLBP-related impairment will be evaluated using the self-reported 24-item Roland-Morris impairment Questionnaire (RMDQ)

Conditions

Back Pain Lower Back Chronic

Outcome Measures

Primary Outcomes (1)

• Evaluation of pregabalin's effectiveness in chronic lower back will be the primary outcomes of this study

  The pain will be measured using numeric rating scale (NRS). It is an 11-point scale (a lower rating suggests improvement in back pain) 0 = no pain, 1-3 = mild pain, 4- 6 = moderate pain, 7-10 = worst/severe pain. CLBP-related impairment will be evaluated using the self-reported 24-item Roland-Morris impairment Questionnaire (RMDQ), which may be scored from 0 to 24

  8 weeks

Study Arms (2)

etoricoxib 60mg

EXPERIMENTAL

tablet etoricoxib 60mg once daily for four weeks

Drug: etoricoxib 60mg

pregabalin 75mg

EXPERIMENTAL

tablet pregabalin 75mg once daily for 4 weeks tablet etoricoxib 60mg once daily for four weeks

Drug: etoricoxib 60mg

Interventions

etoricoxib 60mg DRUG

investigator will compare effects of etoricoxib alone and in combination with pregabalin on pain relief in chronic low back pain participants

Also known as: pregabalin 75mg

etoricoxib 60mg; pregabalin 75mg

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants within age 20-65 years
• Both male and non-pregnant non-lactating female patients will be included in the study
• Patients experiencing CLBP symptoms from last 6 months

You may not qualify if:

• Patients with the history of antidepressant, opioid, and benzodiazepine medications
• Patients with the history of CYP1A2 inhibitors usage
• Patients already taking pregabalin
• Patients with the history of suicidal ideation, severe depression, anxiety disorder psychosis, and cognitive impairment

Sponsors & Collaborators

• Muhammad Ilyas: lead

Related Publications (13)

• Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, Baciarello M, Manferdini ME, Fanelli G. Mechanisms of low back pain: a guide for diagnosis and therapy. F1000Res. 2016 Jun 28;5:F1000 Faculty Rev-1530. doi: 10.12688/f1000research.8105.2. eCollection 2016.

  PMID: 27408698 BACKGROUND

• Fatoye F, Gebrye T, Odeyemi I. Real-world incidence and prevalence of low back pain using routinely collected data. Rheumatol Int. 2019 Apr;39(4):619-626. doi: 10.1007/s00296-019-04273-0. Epub 2019 Mar 8.

  PMID: 30848349 BACKGROUND

• Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, Blyth FM, Smith E, Buchbinder R, Hoy D. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med. 2020 Mar;8(6):299. doi: 10.21037/atm.2020.02.175.

  PMID: 32355743 BACKGROUND

• Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.

  PMID: 26487293 BACKGROUND

• Sakai Y, Ito K, Hida T, Ito S, Harada A. Neuropathic pain in elderly patients with chronic low back painand effects of pregabalin: a preliminary study. Asian Spine J. 2015 Apr;9(2):254-62. doi: 10.4184/asj.2015.9.2.254. Epub 2015 Apr 15.

  PMID: 25901238 BACKGROUND

• Yeole AB, Sree Ranga Lakshmi G, Selvakumar CJ, Goni VG, Nawal CL, Valya BJ, Patel BJ, Patel RD, Pawar ED, Panigrahi R, Kumar AY, Shintre SS, Devkare PH, Dharmadhikari SK, Choudhari SY, Doshi MS, Mehta SC, Joglekar SJ. Efficacy and Safety of Pregabalin Prolonged Release-Etoricoxib Combination Compared to Etoricoxib for Chronic Low Back Pain: Phase 3, Randomized Study. Pain Ther. 2022 Dec;11(4):1451-1469. doi: 10.1007/s40122-022-00437-2. Epub 2022 Oct 12.

  PMID: 36224489 BACKGROUND

• Caglar Okur S, Vural M, Pekin Dogan Y, Mert M, Sayiner Caglar N. The effect of pregabalin treatment on balance and gait in patients with chronic low back pain: a retrospective observational study. J Drug Assess. 2019 Feb 4;8(1):32-35. doi: 10.1080/21556660.2019.1579098. eCollection 2019.

  PMID: 30834164 BACKGROUND

• Otto JC, Forstenpointner J, Sachau J, Hullemann P, Hukauf M, Keller T, Gierthmuhlen J, Baron R. A Novel Algorithm to Identify Predictors of Treatment Response: Tapentadol Monotherapy or Tapentadol/Pregabalin Combination Therapy in Chronic Low Back Pain? Front Neurol. 2019 Sep 13;10:979. doi: 10.3389/fneur.2019.00979. eCollection 2019.

  PMID: 31572292 BACKGROUND

• Igarashi A, Akazawa M, Murata T, Taguchi T, Sadosky A, Ebata N, Willke R, Fujii K, Doherty J, Kobayashi M. Cost-effectiveness analysis of pregabalin for treatment of chronic low back pain in patients with accompanying lower limb pain (neuropathic component) in Japan. Clinicoecon Outcomes Res. 2015 Oct 7;7:505-20. doi: 10.2147/CEOR.S89833. eCollection 2015.

  PMID: 26504403 BACKGROUND

• Fornasari D. Pharmacotherapy for Neuropathic Pain: A Review. Pain Ther. 2017 Dec;6(Suppl 1):25-33. doi: 10.1007/s40122-017-0091-4. Epub 2017 Nov 24.

  PMID: 29178034 BACKGROUND

• Mathieson S, Lin CC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020 Apr 28;369:m1315. doi: 10.1136/bmj.m1315. No abstract available.

  PMID: 32345589 BACKGROUND

• Taguchi T, Nakano S, Nozawa K. Effectiveness of Pregabalin Treatment for Neuropathic Pain in Patients with Spine Diseases: A Pooled Analysis of Two Multicenter Observational Studies in Japan. J Pain Res. 2021 Mar 16;14:757-771. doi: 10.2147/JPR.S293556. eCollection 2021.

  PMID: 33758538 BACKGROUND

• Siddiqui AS, Javed S, Abbasi S, Baig T, Afshan G. Association Between Low Back Pain and Body Mass Index in Pakistani Population: Analysis of the Software Bank Data. Cureus. 2022 Mar 30;14(3):e23645. doi: 10.7759/cureus.23645. eCollection 2022 Mar.

  PMID: 35510015 BACKGROUND

MeSH Terms

Interventions

Etoricoxib; Pregabalin

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Eisha Akram, MBBS,MPhil

CONTACT

00923353048668; eisha80akram@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: senior lecturer

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 6, 2024
• Study Start: June 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: atleast 3 to 6 months after study completion