Safety & Efficacy of Nuberol Forte® in Pain Management

Pain Management Clinical Trial

— NFORT-EFFECT  

Official title:

Clinical Response of Nuberol Forte® for the Pain Management in Musculoskeletal Disorders in Routine Pakistani Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04765787
• Other study ID #: TSCL_NFORT-EFFECT_001
• Status: Completed
• Start date: November 25, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: November 2021
• Source: The Searle Company Limited Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The global prevalence of Musculoskeletal disorders (MSD) ranges from 14% to as high as 42%. In addition WHO also estimates that 40% of people over the age of 60 years suffer from MSD and about 80% of the people have had low back pain at some point in their life. In Pakistan, to estimate the prevalence of MSD, there is no data available based on the local population. Locally, studies were conducted on the specific subject pools mainly considering the work related musculoskeletal disorders and backache. However, no real data is available for the symptomatic management of painful musculoskeletal disorders in multiple settings to calculate more generalizable results. So this study is planned and if we found good results then it will help physicians to prescribe the above said medicine to all such cases.

Description:

The management of musculoskeletal pain is complex therefore plethora of treatment options are available include non-pharmacological treatments , complementary therapies, and pharmacological interventions. In order to provide optimal care to patients with musculoskeletal pain and ensure the efficient use of healthcare resources, a comprehensive overview of the available evidence for the most effective treatment options for musculoskeletal pain presentations is essential. In this context, an observational study is planned on the efficacy and safety of analgesic combination (i.e Nuberol Forte®). Nuberol Forte® is a combination of muscle relaxant (Orphanedrine) and an analgesic/antipyretic (Paracetamol/Acetaminophen). There are clear indications that the combination of Orphenadrine with Paracetamol may give increased antinociceptive activity and duration of action over and above the use of Orphenadrine or Paracetamol alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: August 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient with a clinical history of painful musculoskeletal disorder from last 1 year

• Patient aged =18 and =70 years inclusive of either sex

• Patient with ability to understand and sign written informed consent form.

Exclusion Criteria:

• Known hypersensitivity to Nuberol Forte product, the metabolites, or formulation excipients.

• Patients with Glaucoma, prostatic hypertrophy or obstruction at the bladder neck, myasthenia gravis, oesophageal spasm and pyloric or duodenal obstruction.

• Treated with Nuberol Forte to evaluate safety as per approved prescribing information for Nuberol Forte in Pakistan.

• Pregnant (assesed on LMP) or breast feeding women (assessed on interview).

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Musculoskeletal Disorder
• Pain Management

Intervention

Drug:
• Combination of Paracetamol 650mg + Orphenadrine 50mg
In routine practice for pain , combination of Paracetamol 650 mg + Orphenadrine 50mg prescribed for 7-10 days with follow up and as per physician discretion

Locations

Country	Name	City	State
Pakistan	Liaquat National Hospital	Karachi	Sindh
Pakistan	Medicare Hospital	Karachi	Sindh
Pakistan	Patel Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
The Searle Company Limited Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (13)

Babatunde OO, Jordan JL, Van der Windt DA, Hill JC, Foster NE, Protheroe J. Effective treatment options for musculoskeletal pain in primary care: A systematic overview of current evidence. PLoS One. 2017 Jun 22;12(6):e0178621. doi: 10.1371/journal.pone.0178621. eCollection 2017. Review. — View Citation

Chou R, Peterson K, Helfand M. Comparative efficacy and safety of skeletal muscle relaxants for spasticity and musculoskeletal conditions: a systematic review. J Pain Symptom Manage. 2004 Aug;28(2):140-75. Review. — View Citation

Duffield SJ, Ellis BM, Goodson N, Walker-Bone K, Conaghan PG, Margham T, Loftis T. The contribution of musculoskeletal disorders in multimorbidity: Implications for practice and policy. Best Pract Res Clin Rheumatol. 2017 Apr;31(2):129-144. doi: 10.1016/j.berh.2017.09.004. Epub 2017 Nov 1. Review. — View Citation

GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2. Erratum in: Lancet. 2017 Oct 28;390(10106):e38. — View Citation

Hameed MH, Ghafoor R, Khan FR, Badar SB. Prevalence of musculoskeletal disorders among dentists in teaching hospitals in Karachi, Pakistan. J Pak Med Assoc. 2016 Oct;66(Suppl 3)(10):S36-S38. — View Citation

Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. Review. — View Citation

Høivik HO, Moe N. Effect of a combination of orphenadrine/paracetamol tablets ('Norgesic') on myalgia: a double-blind comparison with placebo in general practice. Curr Med Res Opin. 1983;8(8):531-5. — View Citation

Hunskaar S, Donnell D. Clinical and pharmacological review of the efficacy of orphenadrine and its combination with paracetamol in painful conditions. J Int Med Res. 1991 Mar-Apr;19(2):71-87. Review. — View Citation

McGuinness BW. A double-blind comparison in general practice of a combination tablet containing orphenadrine citrate and paracetamol ('Norgesic') with paracetamol alone. J Int Med Res. 1983;11(1):42-5. — View Citation

Palazzo C, Ravaud JF, Papelard A, Ravaud P, Poiraudeau S. The burden of musculoskeletal conditions. PLoS One. 2014 Mar 4;9(3):e90633. doi: 10.1371/journal.pone.0090633. eCollection 2014. — View Citation

Rathore FA, Attique R, Asmaa Y. Prevalence and Perceptions of Musculoskeletal Disorders Among Hospital Nurses in Pakistan: A Cross-sectional Survey. Cureus. 2017 Jan 26;9(1):e1001. doi: 10.7759/cureus.1001. — View Citation

Straube A, Aicher B, Fiebich BL, Haag G. Combined analgesics in (headache) pain therapy: shotgun approach or precise multi-target therapeutics? BMC Neurol. 2011 Mar 31;11:43. doi: 10.1186/1471-2377-11-43. Review. — View Citation

Syrjala KL, Yi JC, Artherholt SB, Stover AC, Abrams JR. Measuring musculoskeletal symptoms in cancer survivors who receive hematopoietic cell transplantation. J Cancer Surviv. 2010 Sep;4(3):225-35. doi: 10.1007/s11764-010-0126-x. Epub 2010 May 8. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effectiveness of Nuberol Forte from baseline to 2 weeks	the pain, muscle spasm and stiffness are assessed by Muscle & Joint Measure scale.	2 weeks
Primary	To assess the safety of Nuberol Forte in the cases presenting with Musculoskeletal disorder	Safety is monitored from the first dose of the study drug	2 weeks

External Links

•   National Center for Biotechnology Information. PubChem Database. Acetaminophen, CID=1983, (accessed on May 13, 2019)
•   National Center for Biotechnology; Information. PubChem Database. Orphenadrine, CID=4601 (accessed on May 13, 2019)