A Pilot Study Of The Efficacy Of WafermineTM Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Total Pain Relief (TOTPAR)
研究概览
简要总结
To evaluate the safety and effectiveness of Wafermine administered with and without an opioid medication for acute pain following bunionectomy surgery.
详细描述
This is a Phase 2, randomised, double-blind, double-dummy, placebo-controlled evaluation of the analgesic efficacy and safety of WafermineTM alone and in combination with low-dose oxycodone in adult subjects who experience post-operative pain after undergoing primary unilateral bunionectomy. The study will randomise sufficient subjects to have 72 completed subjects at 1 site.
Study subjects will receive multiple doses of study medication over a 14 hour period and will be asked to complete pain and relief assessments as well as tolerability questionnaires over a 24 hour period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Scheduled for a bunionectomy (with no additional procedures).
- •Healthy, ambulatory subjects able to understand and willing to comply with study procedures, study restrictions and requirements.
- •Body mass index (BMI) ≥19 to ≤33 kg/m
- •Females: Not pregnant, not lactating, and not planning to become pregnant during the study.
- •Females: Be abstinent, surgically sterile, at least two years post-menopausal; or medically acceptable contraception.
- •Able to read and understand English.
- •Able to swallow oral capsules whole.
排除标准
- •Allergy, intolerance, or contraindication to ketamine, oxycodone, morphine, ibuprofen or surgical medications.
- •Clinically significant medical condition.
- •History of illicit drug use or alcohol abuse and not in full remission.
- •Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit.
- •Clinically significant 12 lead ECG abnormalities at screening.
- •Smokers who are unwilling to abstain during the inpatient stay.
研究组 & 干预措施
Group F
Wafermine™ 35 mg + placebo wafer given every 4 hours Placebo wafers given every 2 hours Oxycodone 5 mg given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1
干预措施: Oxycodone (Drug)
Group A
Placebo wafers given every 2 hours Placebo capsule given every 4 hours Placebo wafers "top-up" dose given at hour 1
干预措施: Placebo (Drug)
Group B
Placebo wafers given every 2 hours Oxycodone given every 4 hours Placebo wafers "top-up" dose given at hour 1
干预措施: Oxycodone (Drug)
Group C
Wafermine™ 35 mg wafer + placebo wafer given every 2 hours Placebo capsule given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1
干预措施: Wafermine (Drug)
Group D
Wafermine™ 35 mg wafer + placebo wafer given every 2 hours Oxycodone 5 mg capsule every 4 hours Wafermine™ 35 mg "wafer + placebo wafer top-up" dose at hour 1
干预措施: Wafermine (Drug)
Group D
Wafermine™ 35 mg wafer + placebo wafer given every 2 hours Oxycodone 5 mg capsule every 4 hours Wafermine™ 35 mg "wafer + placebo wafer top-up" dose at hour 1
干预措施: Oxycodone (Drug)
Group E
Wafermine™ 35 mg + placebo wafer given every 4 hours Placebo wafers given every 2 hours Placebo capsule given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1
干预措施: Wafermine (Drug)
Group F
Wafermine™ 35 mg + placebo wafer given every 4 hours Placebo wafers given every 2 hours Oxycodone 5 mg given every 4 hours Wafermine™ 35 mg wafer + placebo wafer "top-up" dose at hour 1
干预措施: Wafermine (Drug)
Group G
Wafermine™ 70 mg given every 4 hours Placebo wafer given every 2 hours Placebo capsule given every 4 hours 2 Placebo wafers "top-up" dose at hour 1
干预措施: Wafermine (Drug)
结局指标
主要结局
Total Pain Relief (TOTPAR)
时间窗: 24 hours
Subjects will use an 11 point numerical pain rating scale (NPRS) where 0=No Pain and 10= Worst Possible pain to rate their pain at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5, 16 and 24 hours. TOTPAR is computed as follows at the specified time points: TOTPAR-t = ∑ \[T(i) - T(i-1) \* \[(PR(i-1) + PR(i))/2\]
次要结局
- Time for pain intensity to return to baseline(24 hours)
- Percent with maximum Pain Relief(24 hours)
- Proportion of Subjects requiring "Rescue Medication"(24 hours)
- Time to onset of perceptible and meaningful pain relief(24 hours)
- Responder Rates (30% and 50%)(24 hours)
- Time to rescue medication(24 hours)
- Sum of Pain Intensity Differences (SPID)(24 hours)
- Time to onset of complete pain relief (Peak Relief)(24 hours)
- Time to maximum reduction in pain intensity(24 hours)
- Percentage of Maximum Total Pain Relief (TOTPAR)(24 hours)
- Tolerability (judged by subject answers on oral symptoms questionnaire)(24 hours)
- Safety (treatment emergent adverse events, significant changes in physical examination findings as well as vital sign measurements)(24 hours)