Safety & Efficacy of Nuberol Forte® in Pain Management (NFORT-EFFECT)
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| ClinicalTrials.gov Identifier: NCT04765787 |
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Recruitment Status :
Completed
First Posted : February 21, 2021
Last Update Posted : November 10, 2021
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Sponsor:
The Searle Company Limited Pakistan
Information provided by (Responsible Party):
The Searle Company Limited Pakistan
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Musculoskeletal Disorder Pain Management | Drug: Combination of Paracetamol 650mg + Orphenadrine 50mg |
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.
| Study Type : | Observational |
| Actual Enrollment : | 399 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Clinical Response of Nuberol Forte® for the Pain Management in Musculoskeletal Disorders in Routine Pakistani Practice |
| Actual Study Start Date : | November 25, 2020 |
| Actual Primary Completion Date : | April 1, 2021 |
| Actual Study Completion Date : | August 1, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Non-Drug Pain Management
| Group/Cohort | Intervention/treatment |
|---|---|
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Painful musculoskeletal disorders in random order
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
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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
Other Name: Nuberol Forte |
Primary Outcome Measures :
- 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.
- 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
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Pakistani patients suffering from painful musculoskeletal disorders includes ankle and knee sprains, non-articular low-back pain, painful shoulder lesions (rotator cuff syndrome) and a variety of occupational and sport injuries of the soft tissues in random order. In each case, subjective measures of pain, muscle spasm, stiffness and other symptoms of the musculoskeletal pain will be assessed through Muscle & Joint Measure Scale (MJM). The possible side-effects will be recorded along with other data.The physician will recruit the musculoskeletal patients as per standard practice based on the medical judgment and after review of subject's medical history, results of routine screening, physical and general examination.
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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04765787
Locations
| Pakistan | |
| Liaquat National Hospital | |
| Karachi, Sindh, Pakistan | |
| Medicare Hospital | |
| Karachi, Sindh, Pakistan | |
| Patel Hospital | |
| Karachi, Sindh, Pakistan | |
Sponsors and Collaborators
The Searle Company Limited Pakistan
Investigators
| Study Director: | Asif Mahmood, Dr. | The Searle Company Limited |
Additional Information:
Publications:
Publications:
| Responsible Party: | The Searle Company Limited Pakistan |
| ClinicalTrials.gov Identifier: | NCT04765787 |
| Other Study ID Numbers: |
TSCL_NFORT-EFFECT_001 |
| First Posted: | February 21, 2021 Key Record Dates |
| Last Update Posted: | November 10, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by The Searle Company Limited Pakistan:
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Musculoskeletal Disorder, Nuberol Forte, Pakistan |
Additional relevant MeSH terms:
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Musculoskeletal Diseases Acetaminophen Orphenadrine Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Antiparkinson Agents Anti-Dyskinesia Agents Muscle Relaxants, Central |
Neuromuscular Agents Parasympatholytics Autonomic Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |