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OpenTrials
Completed

NCT Number: NCT04765787

Safety & Efficacy of Nuberol Forte® in Pain Management

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Liaquat National Hospital, Karachi, Sindh, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Combination of Paracetamol 650mg + Orphenadrine 50mg

Drug

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

Other names: Nuberol Forte

Primary outcomes

  1. To assess the effectiveness of Nuberol Forte from baseline to 2 weeks

    Time frame: 2 weeks

    the pain, muscle spasm and stiffness are assessed by Muscle & Joint Measure scale.

  2. To assess the safety of Nuberol Forte in the cases presenting with Musculoskeletal disorder

    Time frame: 2 weeks

    Safety is monitored from the first dose of the study drug

Sponsors and collaborators

Lead sponsor

The Searle Company Limited Pakistan

Industry

Registry information

Official study title

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

Acronym: NFORT-EFFECT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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