Chronic pain is a debilitating condition affecting millions worldwide, often leading to reduced quality of life and functional impairment. Tapentadol, a centrally acting analgesic with dual mechanisms of action, presents a promising option for chronic pain management. This clinical trial aims to assess the efficacy and safety of Tapentadol 100mg in patients with chronic pain.
Study Objectives:
Primary Objective: To evaluate the analgesic efficacy of Tapentadol 100mg compared to placebo in reducing pain intensity over a 12-week treatment period.
Secondary Objectives:
- To assess the impact of Tapentadol 100mg on pain interference with daily activities.
- To evaluate the safety and tolerability of Tapentadol 100mg.
- To investigate the effects of Tapentadol 100mg on quality of life and functional outcomes.
Study Design:
This will be a randomized, double-blind, placebo-controlled trial conducted at multiple centers.
Eligible participants will be randomized in a 1:1 ratio to receive either Tapentadol 100mg or placebo orally twice daily for 12 weeks.
Pain intensity will be assessed using validated pain scales at baseline and regular intervals throughout the study period.
Adverse events, quality of life measures, and functional outcomes will also be monitored.
- Study Population:
Inclusion Criteria:
Adults aged 18-75 years with a diagnosis of chronic pain (of at least 3 months duration) of moderate to severe intensity.
Pain intensity score of ≥4 on an 11-point numerical rating scale (NRS).
Exclusion Criteria:
Contraindications to Tapentadol use, including hypersensitivity, respiratory depression, and paralytic ileus.
History of substance abuse or dependence.
Concurrent use of other opioids or centrally acting medications.
- Study Assessments:
Primary Outcome Measure:
Change in average pain intensity from baseline to week 12, assessed using an 11-point numerical rating scale (NRS).
Secondary Outcome Measures:
- Pain interference with daily activities, assessed using the Brief Pain Inventory (BPI).
- Incidence and severity of adverse events.
- Quality of life, assessed using validated questionnaires (e.g., SF-36).
- Functional outcomes, including physical function and sleep quality.
- Statistical Analysis:
Sample size calculation based on previous studies estimating a 30% reduction in pain intensity with Tapentadol compared to placebo, with a power of 80% and alpha level of 0.05.
Descriptive statistics will be used to summarize demographic and clinical characteristics.
Inferential statistics, including t-tests and chi-square tests, will be used to analyze primary and secondary outcome measures.
- Ethics and Safety:
The study protocol will be reviewed and approved by the Institutional Review Board (IRB) or Ethics Committee at each participating site.
Informed consent will be obtained from all participants before enrollment.
Data safety monitoring will be conducted throughout the study to ensure participant safety and data integrity.
Conclusion:
This clinical trial aims to provide valuable insights into the efficacy and safety of Tapentadol 100mg in the management of chronic pain. By rigorously evaluating its analgesic properties and impact on patient outcomes, this study seeks to inform clinical practice and improve the care of individuals suffering from chronic pain.
