Safety & Efficacy of Nuberol Forte® in Pain Management

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

Sponsors

Lead Sponsor: The Searle Company Limited Pakistan

Source The Searle Company Limited 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.

Overall Status Recruiting
Start Date 2020-11-25
Completion Date 2021-08-01
Primary Completion Date 2021-04-01
Study Type Observational
Primary Outcome
Measure Time Frame
To assess the effectiveness of Nuberol Forte from baseline to 2 weeks 2 weeks
To assess the safety of Nuberol Forte in the cases presenting with Musculoskeletal disorder 2 weeks
Enrollment 520
Condition
Intervention

Intervention Type: Drug

Intervention Name: Combination of Paracetamol 650mg + Orphenadrine 50mg

Description: 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

Arm Group Label: Painful musculoskeletal disorders in random order

Other Name: Nuberol Forte

Eligibility

Sampling Method:

Probability Sample

Criteria:

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).

Gender:

All

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Asif Mahmood, Dr. Study Director The Searle Company Limited
Overall Contact

Last Name: Ali Y Khan, Dr.

Phone: 00922137170201

Phone Ext.: 2203

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
Liaquat National Hospital | Karachi, Sindh, Pakistan Recruiting Prof. Dr Shahid Noor, MD Prof. Dr. Shahid Noor, MD Principal Investigator
Medicare Hospital | Karachi, Sindh, Pakistan Recruiting Dr. Kazim Najjad Dr. Kazim Najjad Principal Investigator
Patel Hospital | Karachi, Sindh, Pakistan Recruiting Dr. M. Nasir Dr. M. Nasir Principal Investigator
Location Countries

Pakistan

Verification Date

2020-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: 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

Acronym NFORT-EFFECT
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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