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NCT04765787 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

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Study Design

Related Conditions & MeSH terms

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)

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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
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