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Safety & Efficacy of Nuberol Forte® in Pain Management

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04765787
Acronym
NFORT-EFFECT
Enrollment
399
Registered
2021-02-21
Start date
2020-11-25
Completion date
2021-08-01
Last updated
2021-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Disorder, Pain Management

Keywords

Musculoskeletal Disorder, Nuberol Forte, Pakistan

Brief 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.

Detailed 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.

Interventions

DRUGCombination 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

Sponsors

The Searle Company Limited Pakistan
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
To assess the effectiveness of Nuberol Forte from baseline to 2 weeks2 weeksthe pain, muscle spasm and stiffness are assessed by Muscle & Joint Measure scale.
To assess the safety of Nuberol Forte in the cases presenting with Musculoskeletal disorder2 weeksSafety is monitored from the first dose of the study drug

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026