- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04765787
Safety & Efficacy of Nuberol Forte® in Pain Management (NFORT-EFFECT)
November 8, 2021 updated by: The Searle Company Limited Pakistan
Clinical Response of Nuberol Forte® for the Pain Management in Musculoskeletal Disorders in Routine Pakistani Practice
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
399
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Sindh
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Karachi, Sindh, Pakistan
- Liaquat National Hospital
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Karachi, Sindh, Pakistan
- Medicare Hospital
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Karachi, Sindh, Pakistan
- Patel Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 weeks
|
To assess the safety of Nuberol Forte in the cases presenting with Musculoskeletal disorder
Time Frame: 2 weeks
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Safety is monitored from the first dose of the study drug
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Asif Mahmood, Dr., The Searle Company Limited
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
- GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2. Erratum In: Lancet. 2017 Oct 28;390(10106):e38.
- Duffield SJ, Ellis BM, Goodson N, Walker-Bone K, Conaghan PG, Margham T, Loftis T. The contribution of musculoskeletal disorders in multimorbidity: Implications for practice and policy. Best Pract Res Clin Rheumatol. 2017 Apr;31(2):129-144. doi: 10.1016/j.berh.2017.09.004. Epub 2017 Nov 1.
- Palazzo C, Ravaud JF, Papelard A, Ravaud P, Poiraudeau S. The burden of musculoskeletal conditions. PLoS One. 2014 Mar 4;9(3):e90633. doi: 10.1371/journal.pone.0090633. eCollection 2014.
- Babatunde OO, Jordan JL, Van der Windt DA, Hill JC, Foster NE, Protheroe J. Effective treatment options for musculoskeletal pain in primary care: A systematic overview of current evidence. PLoS One. 2017 Jun 22;12(6):e0178621. doi: 10.1371/journal.pone.0178621. eCollection 2017.
- Chou R, Peterson K, Helfand M. Comparative efficacy and safety of skeletal muscle relaxants for spasticity and musculoskeletal conditions: a systematic review. J Pain Symptom Manage. 2004 Aug;28(2):140-75. doi: 10.1016/j.jpainsymman.2004.05.002.
- Straube A, Aicher B, Fiebich BL, Haag G. Combined analgesics in (headache) pain therapy: shotgun approach or precise multi-target therapeutics? BMC Neurol. 2011 Mar 31;11:43. doi: 10.1186/1471-2377-11-43.
- Hoivik HO, Moe N. Effect of a combination of orphenadrine/paracetamol tablets ('Norgesic') on myalgia: a double-blind comparison with placebo in general practice. Curr Med Res Opin. 1983;8(8):531-5. doi: 10.1185/03007998309109793.
- McGuinness BW. A double-blind comparison in general practice of a combination tablet containing orphenadrine citrate and paracetamol ('Norgesic') with paracetamol alone. J Int Med Res. 1983;11(1):42-5. doi: 10.1177/030006058301100109.
- Hunskaar S, Donnell D. Clinical and pharmacological review of the efficacy of orphenadrine and its combination with paracetamol in painful conditions. J Int Med Res. 1991 Mar-Apr;19(2):71-87. doi: 10.1177/030006059101900201.
- Syrjala KL, Yi JC, Artherholt SB, Stover AC, Abrams JR. Measuring musculoskeletal symptoms in cancer survivors who receive hematopoietic cell transplantation. J Cancer Surviv. 2010 Sep;4(3):225-35. doi: 10.1007/s11764-010-0126-x. Epub 2010 May 8.
- Hameed MH, Ghafoor R, Khan FR, Badar SB. Prevalence of musculoskeletal disorders among dentists in teaching hospitals in Karachi, Pakistan. J Pak Med Assoc. 2016 Oct;66(Suppl 3)(10):S36-S38.
- Rathore FA, Attique R, Asmaa Y. Prevalence and Perceptions of Musculoskeletal Disorders Among Hospital Nurses in Pakistan: A Cross-sectional Survey. Cureus. 2017 Jan 26;9(1):e1001. doi: 10.7759/cureus.1001.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 25, 2020
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
August 1, 2021
Study Registration Dates
First Submitted
February 19, 2021
First Submitted That Met QC Criteria
February 19, 2021
First Posted (Actual)
February 21, 2021
Study Record Updates
Last Update Posted (Actual)
November 10, 2021
Last Update Submitted That Met QC Criteria
November 8, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Cytochrome P-450 Enzyme Inhibitors
- Neuromuscular Agents
- Muscle Relaxants, Central
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Cytochrome P-450 CYP2B6 Inhibitors
- Acetaminophen
- Orphenadrine
Other Study ID Numbers
- TSCL_NFORT-EFFECT_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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