NCT01356225已完成2 期
A Randomized, Double-blind, Placebo-controlled, Parallel, Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Egalet Ltd
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Summed Pain Intensity Difference (SPID)
研究概览
简要总结
The purpose of this study is to evaluate the analgesic efficacy of a single intranasal (IN) administration of ketorolac after dental impaction surgery.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, age 18 years or older.
- •Body weight > or = to 100 pounds and < or = 300 pounds.
- •Women of childbearing potential must have a negative serum pregnancy test result prior to entry into the study.
- •Able to provide written informed consent.
- •At least moderate pain as determined by a PI score of > or = to 50 mm on a 100-mm VAS.
- •Willing and able to comply with all testing and requirements defined in the protocol.
- •Willing and able to complete the posttreatment visit.
- •Immediately prior to entering the study, surgical removal of 3 or 4 third molars (at least 1 mandibular partial bony or complete bony impaction).
排除标准
- •Allergy or sensitivity to ketorolac or EDTA.
- •Allergic reaction to aspirin or other NSAIDs.
- •Current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of adverse events (AEs).
- •Use of any IN product within 24 hours prior to study entry.
- •Clinically significant abnormality on screening laboratory tests.
- •History of cocaine use resulting in nasal mucosal damage.
- •Active peptic ulcer disease, recent (defined as within 6 months) history of peptic ulcer disease or gastrointestinal bleeding considered by the investigator to be clinically significant.
- •Advanced renal impairment (serum creatinine >1.5 mg/dL) or a risk for renal failure due to volume depletion.
- •A history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation.
- •Participation within 30 days of study entry or within 5 times the half- life, whichever is longer, in another investigational drug study.
- •Pregnancy or breastfeeding.
- •Extraction of teeth other than third molars during the surgical procedure; exceptions:(1) supernumerary third molars; (2) cases whereby extraction of a third molar requires the removal of an adjacent molar.
- •Previous participation in this study.
- •Use of any short-acting NSAID (such as aspirin or ibuprofen) or acetaminophen within 12 hours of surgery.
- •Use of longer-acting NSAIDs (such as naproxen sodium) within 48 hours of surgery or piroxicam within 7 days of surgery.
- •Use of steroids (other than oral contraceptives) within 72 hours of surgery.
- •Use of mood-altering drugs, such a cannabis or alcohol, within 12 hours of surgery.
- •Surgical anesthesia including narcotic agents except fentanyl. Short-acting anesthetics, both DEA scheduled and unscheduled, were allowed. Naloxone in any form was not permitted.
- •Use of any other medication within 24 hours prior to surgery that, in the opinion of the investigator, could confound the subject's efficacy assessments (eg, sedatives, tranquilizers, MAO inhibitors, phenothiazines).
- •Consumption of any caffeine-containing products within 4 hours of surgery.
研究组 & 干预措施
Intranasal Ketorolac tromethamine
Experimental
干预措施: Ketorolac tromethamine (Drug)
Intranasal placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Summed Pain Intensity Difference (SPID)
时间窗: 8 hours postdose
Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. The PI values were obtained at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours following the first dose of study medication on Day 1. Pain intensity difference (PID) was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. A summed PID (SPID) on the first postoperative day was calculated at 8 hours.
次要结局
- Summed Pain Intensity Difference (SPID)(4 and 6 hours postdose)
- Total Pain Relief (TOTPAR)(4, 6, and 8 hours postdose)
- Pain intensity difference (PID) and pain relief scores(Before receiving study drug (baseline), at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours postdose)
- Peak PID score(4, 6, and 8 hours postdose)
- Peak pain relief scores(4, 6, and 8 hours postdose)
- Time to onset of perceptible pain and meaningful pain relief(After study drug administration until perceptible and meaningful pain relief was felt (during the 8-hour postdose observation period))
- Time to first use of rescue medication(After study drug administration until rescue analgesic therapy was requested (during the 8-hour postdose observation period))
- Proportion of subjects taking rescue medication(During 8-hour postdose observation period)
- Global pain control(At the end of the 8-hour observation period, or at the time the subject took rescue analgesic medication if prior to 8 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Pilot Study In Adults And Adolescents With Irritant (Non-Allergic) RhinitisRhinitis, Allergic, PerennialNCT00730756GlaxoSmithKline102
已完成
4 期
A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic RhinitisRhinitis, Allergic, PerennialNCT00609674GlaxoSmithKline315
已完成
不适用
Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry EyeDry Eye SyndromesNCT02313454Allergan21
已完成
1 期
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult ParticipantsHealthyNCT02345148Janssen Research & Development, LLC16
终止
不适用
Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal PainCorneaNCT03674892Tufts Medical Center21