Safety & Efficacy of Nuberol Forte® in Pain Management (NFORT-EFFECT)

The Searle Company

Status

Completed

Conditions

Musculoskeletal Disorder

Pain Management

Treatments

Drug: Combination of Paracetamol 650mg + Orphenadrine 50mg

Study type

Observational

Funder types

Industry

Identifiers

NCT04765787

TSCL_NFORT-EFFECT_001

Details and patient eligibility

About

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.

Full 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.

Enrollment

399 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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).

Trial design

399 participants in 1 patient group

Painful musculoskeletal disorders in random order

Description:

Nuberol Forte® (Paracetamol 650 mg + Orphenadrine 50 mg) for the symptomatic management of the painful musculoskeletal disorders one tablet three times a day or as per physician discretion or as per severity of pain and treatment duration is 7-10 days

Treatment:

Drug: Combination of Paracetamol 650mg + Orphenadrine 50mg