Randomized, Double-blind, Parallel Group, Single-center, Placebo-controlled Study to Evaluate Efficacy and Safety of Analgesic Combo in Prevention and Treatment of Post-surgical Dental Pain in Healthy Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Total Pain Relief Measure
研究概览
简要总结
- Accessing the efficacy and safety of pregabalin when used alone and in combo with acetaminophen in a dental pain model.
- To test whether pre-operative dose of pregabalin increases the time to significant post-operative pain (NRS ≥ 5), and hence time to first analgesia consumed post-operatively.
详细描述
This is a 5 arm randomized, double-blind, parallel group, single-center, placebo-controlled study to evaluate the efficacy and safety of pregabalin-acetaminophen combination in the prevention and treatment of post-surgical dental pain in healthy patients.
Subjects in every treatment arm will receive a dose 60 min prior to surgery. It is not required to receive a post-operative dose if patient does not feel pain at a scale of NRS≥ 5. Dose 2 will be given post-surgically when patients report at least moderate pain on the categorical scale and a score of ≥5 on 0-10 PI-NRS. Subsequent to dose 2, patients can request rescue analgesic at any time.
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
- Double (Participant, Investigator)
盲法说明
The sponsor, patients, investigators and study staff involved in the protocol procedures or those involved in data collection, data entry, data analysis will be blinded.
入排标准
- 年龄范围
- 17 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are scheduled to undergo the surgical removal of up to 4 third molars of which at least 2 have to be mandibular molars with a difficulty rating of 4 or
- •Patient must have a negative urine drug screen for drugs of abuse (including tobacco) at screening and at the day of surgery.
- •No alcohol for a minimum of 1 day prior to the surgery.
排除标准
- •Patients should not be experiencing oral infections or symptoms of concomitant illness at the time of a scheduled surgery.
- •Patients with a history of any type of malignancy within the past 5 years other than minor skin related cancers.
- •Patients who currently have or have had a history of uncontrolled hypertension.
- •Patients with a known allergy or hypersensitivity to any local anesthetic drug, NSAIDs, gabapentin or pregabalin;.
- •Patients with conditions that affect the absorption, metabolism, or passage of drugs out of the body (e.g., sprue, celiac disease, crohn's disease, etc.)
研究组 & 干预措施
Group A
Pre-op Placebo 1;
Post-op Placebo 1;
Post-op Placebo 2
干预措施: Pre-Op Placebo 1 (Drug)
Group A
Pre-op Placebo 1;
Post-op Placebo 1;
Post-op Placebo 2
干预措施: Post-Op Placebo 1 (Drug)
Group A
Pre-op Placebo 1;
Post-op Placebo 1;
Post-op Placebo 2
干预措施: Post-Op Placebo 2 (Drug)
Group B
Pre-op Placebo 1;
Post-op Placebo 2;
Post-op acetaminophen.
干预措施: Pre-Op Placebo 1 (Drug)
Group B
Pre-op Placebo 1;
Post-op Placebo 2;
Post-op acetaminophen.
干预措施: Post-Op Placebo 1 (Drug)
Group B
Pre-op Placebo 1;
Post-op Placebo 2;
Post-op acetaminophen.
干预措施: Post-Op acetaminophen (Drug)
Group C
Pre-op Placebo 1;
Post-op pregabalin;
Post-op Placebo 2.
干预措施: Pre-Op Placebo 1 (Drug)
Group C
Pre-op Placebo 1;
Post-op pregabalin;
Post-op Placebo 2.
干预措施: Post-Op pregabalin (Drug)
Group C
Pre-op Placebo 1;
Post-op pregabalin;
Post-op Placebo 2.
干预措施: Post-Op Placebo 2 (Drug)
Group D
Pre-op Placebo 1;
Post-op pregabalin
Post-op acetaminophen.
干预措施: Pre-Op Placebo 1 (Drug)
Group D
Pre-op Placebo 1;
Post-op pregabalin
Post-op acetaminophen.
干预措施: Post-Op pregabalin (Drug)
Group D
Pre-op Placebo 1;
Post-op pregabalin
Post-op acetaminophen.
干预措施: Post-Op acetaminophen (Drug)
Group E
Pre-op pregabalin;
Post-op Placebo 1;
Post-op acetaminophen.
干预措施: Pre-Op pregabalin (Drug)
Group E
Pre-op pregabalin;
Post-op Placebo 1;
Post-op acetaminophen.
干预措施: Post-Op Placebo 1 (Drug)
Group E
Pre-op pregabalin;
Post-op Placebo 1;
Post-op acetaminophen.
干预措施: Post-Op acetaminophen (Drug)
结局指标
主要结局
Total Pain Relief Measure
时间窗: 0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)
Beginning post-surgery (at initiation of Dose 2), Pain Relief was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time-weighted sum pain total pain relief scores over 24 hours is reported Last observation carried forward method was used.
Sum Pain Intensity Difference Scores
时间窗: 0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)
Beginning post-surgery (at initiation of Dose 2), Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time weighted sum pain intensity difference scores are reported over 0 to 24 hours. Last observation carried forward method was used.
次要结局
- Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2(0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours)
- Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After Dose 2(0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours)
- Number of Participants With Differing Patient Global Evaluation Scores(Upto 12.25 hours)