NCT02222740已完成2 期
A Multiple-Dose, Safety, Tolerability, and Pharmacokinetic Dose-Escalation Study of Hydrocodone Bitartrate Extended Release (HC-ER) in Patients With Chronic, Moderate to Severe Osteoarthritis Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Assess the steady-state pharmacokinetics (PK) of multiple dose of 10, 20, 30, and 40 mg of HC-ER
研究概览
简要总结
Assess the safety, tolerability and pharmacokinetics of multiple doses of 10, 20, 30, and 40 mg of Hydrocodone Bitartrate Extended Release (HC-ER)capsules taken with food at steady state, in subjects with chronic, moderate to severe osteoarthritis (OA) pain.
详细描述
Safety parameters assessed included adverse events, physical examinations, vital signs, 12-lead electrocardiogram (ECGs), clinical laboratory testing and overall Arthritis Pain Intensity and opioid side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Subjects were 18 years or older
- •Subjects had osteoarthritis (OA) defined by:
- •Presence of of typical hip and/or knee joint symptoms. Involvement of at least 1 hip or knee joints that had warranted treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including cyclooxygenase-2 [COX-2] inhibitors and/or acetaminophen (APAP) for the last 3 months.
- •Radiographic evidence within the last 6 months of OA in the index joint, with Grade II to IV severity, as illustrated by the Atlas of Standard Radiographs.
- •Subjects were otherwise in generally good health, as determined by the investigator, on the basis of medical history, physical examination, electrocardiogram (ECG), and screening laboratory results.
- •Female subjects were either physically incapable of childbearing or were practicing an acceptable method of birth control and had a negative pregnancy test result demonstrated before dosing.
- •Subjects had experienced a suboptimal response to APAP and NSAID therapy (including COX-2 inhibitor).
- •Subjects had used opioids for OA pain on an as needed (PRN) or occasional basis.
- •Subjects were willing and able to discontinue or modify their current medication used for management of OA pain per protocol.
- •Subjects had steady, not transient, pain and a categorical pain rating of moderate to severe on a scale of none, mild, moderate, or severe.
- •Subjects weighed > or = to100 lbs.
- •If a subject had taken any inducers or inhibitors of cytochrome P450 [CYP450j), these were discontinued and an appropriate washout period (5 half-lives) had occurred before entry in the study.
- •Subjects were able to take oral medication and were willing to comply with the protocol.
- •Subjects agreed to abstain from alcohol consumption for the duration of the study.
- •Subjects were able to read, understand, and voluntarily sign the IRB approved consent document before the performance of any study-specific procedures.
排除标准
- •Subjects had any clinically significant condition that would, in the investigator's opinion, preclude study participation.
- •Subjects had any other clinically significant form of disease at the index joint (study joint) or had been diagnosed with inflammatory arthritis, gout, pseudo-gout, Paget's disease, or any other chronic pain syndrome that, in the investigator's opinion, might interfere with the assessment of pain and other symptoms of OA.
- •Subjects had known allergies or previous, significant reactions to opioids.
- •Subjects had any laboratory abnormality at screening that was considered clinically significant by the investigator, or that, in the opinion of the investigator, would have contraindicated study participation.
- •Subjects were known to have positive test results for human immunodeficiency virus (HIV), hepatitis B antigen, or hepatitis C antibody.
- •Subjects had a history of chronic, scheduled opioid use for OA.
- •Subjects had any signs or symptoms of opioid withdrawal.
- •Subjects had a history of substance or alcohol abuse within 2 years before study entry.
- •Subjects tested positively on a urine screen for drugs of abuse.
- •Subjects had received any steroid therapy (e.g., oral, intramuscular, intravenous, or soft tissue) within 1 month of study entry.
- •Subjects had a condition that would contraindicate the use of opioid analgesia.
- •Subjects had participated in a study of an investigational drug or device, or had donated blood, within 30 days before study entry.
- •Subjects used any medication that the investigator felt would interact unfavorably with the study medication (e.g., potentiation of sedation with tricyclic antidepressants).
- •Subjects had used opioid analgesics for more than 3 days during the 30 days before screening.
- •Subjects had a history of seizures.
- •Subjects were considered by the investigator to be unsuitable for any reason.
研究组 & 干预措施
Group 1
Experimental
10 mg of Hydrocodone Bitartrate Extended Release (HC-ER) Twice per day (BID) for 7 days, followed by 20 mg BID for 7 days, followed by 30 mg BID for 7 days
干预措施: 10 mg of Hydrocodone Bitartrate Extended Release (HC-ER) (Drug)
Group 2
Experimental
20 mg of Hydrocodone Bitartrate Extended Release (HC-ER) Twice Per Day (BID) for 7 days, followed by 30 mg BID for 7 days, followed by 40 mg BID for 7 days
干预措施: 20 mg of Hydrocodone Bitartrate Extended Release (HC-ER) (Drug)
结局指标
主要结局
Assess the steady-state pharmacokinetics (PK) of multiple dose of 10, 20, 30, and 40 mg of HC-ER
时间窗: Day 1-28
PK parameters including Tmax, Cmax and Cmin were calculated for each dose level in each group from the PK profile of hydrocodone and the metabolites hydromorphone, and norhydrocodone.
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Safety and Pharmacokinetic Study With Multiple Ascending Doses of ORM-12741HealthyNCT01068028Orion Corporation, Orion Pharma49
已完成
1 期
MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).Diabetes Mellitus, Non-Insulin-DependentNCT00754130Merck Sharp & Dohme LLC16
终止
1 期
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase InhibitorsAlzheimer's DiseaseNCT02220738AbbVie19
已完成
1 期
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate AsthmaAsthmaNCT01370317Merck Sharp & Dohme LLC27
Unknown
1 期
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.Chronic Hepatitis bNCT04277897Xi'an Xintong Pharmaceutical Research Co.,Ltd.69