Double-blind, Randomised, Placebo and Active Controlled, Parallel Group Study to Evaluate the Analgesic Effect of a Single Oral Administration of Four Different Combination Doses of DKP.TRIS With TRAM.HCL in Comparison With the Single Agents, on Moderate to Severe Pain Following Impacted Third Mandibular Molar Tooth Extraction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 745
- 试验地点
- 16
- 主要终点
- Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.
研究概览
简要总结
The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.
详细描述
The aim of this study is to develop a combination of Dexketoprofen Trometamol (DKP.TRIS) and Tramadol Hydrochloride (TRAM.HCl) for the treatment of acute moderate to severe pain, based on the rationale that more than one drug is necessary in most patients suffering of acute and chronic pain, particularly of moderate to severe intensity.
DKP.TRIS and TRAM.HCl have different mechanisms of action, therefore their combination is expect to result in an additive or synergistic analgesia, thus allowing a decrease in the required doses of the individual agents, and consequently a reduced risk of adverse events In this study, patients who present moderate to severe pain after impacted third mandibular molar tooth extraction will be randomised to a total of 10 treatment arms including 4 combinations of DKP.TRIS + TRAM.HCl, the four corresponding single treatments, placebo and ibuprofen. Treatment administration will be followed by a 24-hour pain and analgesic effect assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting ALL the following criteria will be eligible for entry into the study:
- •Male or female patients aged 18 to 70 years old. Females participating in the study must be either: of non-childbearing potential, or willing to use a highly effective contraceptive method.
- •Scheduled for outpatient surgical extraction -under local anaesthesia- of third mandibular molar teeth, with at least one of which is fully or partially impacted in the mandible requiring bone manipulation.
- •Normal physical examination or without clinically relevant abnormalities.
- •At randomisation (after surgery):
- •No intake of analgesics (including prescription and over the counter drugs) within 24h prior to the surgery.
- •No complication during the surgery, duration of surgery < 1 hour and not requiring re-anaesthesia.
- •Patients experiencing pain of moderate or higher intensity in the first four hours after the end of surgery.
排除标准
- •History of allergy or hypersensitivity to NSAIDs, opioids or acetyl salicylic acid.
- •History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic oedema.
- •History of peptic ulcer, gastrointestinal disorders by NSAIDs, gastrointestinal bleeding or other active bleedings.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Ibuprofen
干预措施: Ibuprofen (Drug)
TRAM.HCl high dose
干预措施: Tramadol Hydrochloride (Drug)
TRAM.HCl low dose
干预措施: Tramadol Hydrochloride (Drug)
DKP-TRIS high dose
干预措施: Dexketoprofen Trometamol (Drug)
DKP-TRIS low dose
干预措施: Dexketoprofen Trometamol (Drug)
DKP-TRIS low dose - TRAM.HCl low dose
干预措施: Dexketoprofen Trometamol + Tramadol Hydrochloride (Drug)
DKP-TRIS low dose - TRAM.HCl high dose
干预措施: Dexketoprofen Trometamol + Tramadol Hydrochloride (Drug)
DKP-TRIS high dose - TRAM.HCl low dose
干预措施: Dexketoprofen Trometamol + Tramadol Hydrochloride (Drug)
DKP-TRIS high dose - TRAM.HCl high dose
干预措施: Dexketoprofen Trometamol + Tramadol Hydrochloride (Drug)
结局指标
主要结局
Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.
时间窗: 6 hours
Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %
次要结局
- Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.(4, 8 and 12 hours)
- Percentage of Patients Using Rescue Medication at 6 Hours(Baseline to 6 hours)