A Phase 1, Double-Blind, Study of the Tolerability of Formulations of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Egalet Ltd
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Discomfort Measurement on a Visual Analogue Scale
研究概览
简要总结
This was a Phase 1, double blind, two part study in healthy male and female volunteers. Each subject participated in only one part of the study. In Part A subjects received one dose of 15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the other nostril, in a randomized manner. In Part B subjects were randomized to receive a single intranasal dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into one nostril and either placebo or a single intranasal dose of 15 mg ketorolac tromethamine containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril. During the study, subjects remained resident from the morning of Day 1 until the afternoon of Day 1, when a post-study medical was performed prior to discharge.
The objective of this study was to compare the tolerability of formulations of ketorolac tromethamine with differing concentrations of lidocaine hydrochloride (0% and 6% in Part A and 0%, 4%, 6% and placebo in Part B) following intranasal administration to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers, aged 18 to 60 years inclusive
- •Female subjects of child bearing potential must have had a negative urine pregnancy test prior to entry into the study and must not have been breast feeding
- •All female subjects of child bearing potential and all male subjects with female partners of child bearing potential must have consented to use a medically acceptable method of contraception (oral or implanted contraceptive hormones, condom or diaphragm with spermicidal agent, intrauterine device or surgical sterilization) throughout the study period
- •Subject had given signed informed consent
- •Subject was within 20% of normal weight for his/her height and body build according to the table of "Desirable Weights for Men and Women" (Metropolitan Life Insurance Co. 1999)
- •Subject's medical history was considered normal, with no clinically significant abnormalities
- •Subject was considered to be in good health in the opinion of the Investigator, as determined by a pre-study physical examination with no clinically significant abnormalities, vital signs within normal ranges and an electrocardiogram (ECG) with no clinically significant abnormalities
- •Subject's pre-study clinical laboratory findings were within the normal range or if outside of the normal range were not deemed clinically significant in the opinion of the Investigator
- •Subject had bilateral patent nasal airways at screening and Day 1 as assessed by the Investigator
- •Body weight of at least 60 kg
排除标准
- •Subject had had a clinically significant illness in the four weeks before screening
- •Use of prescribed medications in the three weeks prior to dosing or over-the-counter preparations for seven days prior to dosing, except paracetamol which was allowed up to 48 hours prior to dosing. However, use of multivitamins and oral contraceptives were permitted
- •Subject had a significant history of drug/solvent abuse, or a positive drugs of abuse test at screening
- •Subject had a history of alcohol abuse or currently drank in excess of 28 units per week (males) or 21 units per week (females)
- •Current tobacco use or a history of smoking within the past five years
- •Subject was in the opinion of the Investigator not suitable to participate in the study
- •Subject had participated in any clinical study with an investigational drug/device within three months prior to dosing
- •Subject had a positive result of human immunodeficiency virus (HIV) screen, Hepatitis B screen or Hepatitis C screen
- •Subject had had a serious adverse reaction or significant hypersensitivity to any drug
- •Subject had donated 500 mL or more of blood within the three months prior to screening
- •Any history of co-existing nasal polyps, NSAID sensitivity and asthma
- •Allergic reaction to aspirin or other NSAIDs
- •Current upper respiratory tract infection or other respiratory tract condition that could have interfered with the absorption of the nasal spray or with the assessment of adverse events (AEs)
- •Any suspicion of rhinitis medicamentosa (chronic daily use of topical decongestants)
- •Use of a monoamine oxidase inhibitor in the 14 days prior to study entry
- •Active peptic ulcer disease, gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding
- •Anemia due to unexplained or known gastrointestinal bleeding
- •History of asthma or any other chronic pulmonary disorder
- •Renal impairment or a risk of renal failure due to volume depletion
- •Known sensitivity to lidocaine hydrochloride
- •Previous history of nasal surgery
研究组 & 干预措施
Ketorolac tromethamine (Part A)
干预措施: Ketorolac tromethamine (Drug)
Ketorolac tromethamine (Part B)
干预措施: Ketorolac tromethamine (Drug)
结局指标
主要结局
Discomfort Measurement on a Visual Analogue Scale
时间窗: 15 minutes post-dose
Following administration of each treatment, subjects completed a visual analogue scale (VAS) (ranging from "no discomfort" to "severe discomfort") at 1, 5, 10 and 15 minutes post-dose. If after the 15 minute VAS assessment discomfort was still present the subject was asked to complete further VAS assessments, at 5 minute intervals, until the discomfort had dissipated.
次要结局
未报告次要终点