Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo
研究概览
简要总结
The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.
详细描述
The study will be prospective, double-blinded and randomized. The study will run for 12 weeks. During the first 7 weeks there will be 2 groups in the study with subjects receiving a placebo or the study drug. During the last 4 weeks of the study, all subjects will be offered the study medication, pregabalin. The primary outcome measure will be pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinding was done to ensure minimum bias. Clinicians were not involved in the randomization process. Patients and clinicians were blinded to the identity of the drug as a look alike placebo was used. The randomization code was was maintained by the research assistant and kept in a locked file cabinet. Separated individuals generated the allocation sequence. The blind was maintained until all the decisions regarding data evaluability were made or in the event of a serious adverse event.
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
- •Must have history of prior surgery and documented adhesions during laparoscopy or open laparotomy within 5 years
- •Must have undergone an evaluation to exclude other causes of abdominal pain
- •Abdominal pain must be present for greater than three months duration
排除标准
- •Patients that are pregnant or breast feeding
- •Prior treatment with gabapentin, pregabalin or demonstrated sensitivity to these drugs
- •Patients who are immunocompromised
- •Patients with significant hepatic or renal insufficiency, or any significant hematologic disorder
- •History of illicit alcohol or drug abuse within one year
- •Documented serious or unstable medical or psychological condition
- •Malignancy within the past 5 years other than in situ squamous cell carcinoma of the skin
研究组 & 干预措施
Pregabalin 150 or 300 mg daily for severe abdominal pain from adhesions
Patients were randomly assigned to active drug 75-150 mg of pregabalin po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.
干预措施: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks (Drug)
Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions
Patients were randomly assigned to look alike placebo 75 or 150 mg po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.
干预措施: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks (Drug)
Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions
Patients were randomly assigned to look alike placebo 75 or 150 mg po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.
干预措施: Placebo first followed by open label pregabalin (Drug)
结局指标
主要结局
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo
时间窗: Baseline and week 2 through week 12
Patients were randomized to pregabalin or placebo 75 mg twice a day. Patients were allowed to double the dose on day 3 if adequate pain relief was not obtained. Abdominal pain reduction was measured on a Likert scale. A Likert scale assumes the intensity of pain is linear on a continuum from no pain at level 0 to severe pain at level 10. Patients were required to complete a daily dairy recording pain using the Likert 11-point numeric scale. The primary end point was a positive change in the daily pain diary of 2 points from each patient's baseline at weeks 8 after the completion of the blinded study and at week 12 during the open label portion of the study. After 7 weeks all patients are randomized to study drug pregabalin 150 to 300 mg daily for 4 additional weeks after a one week wash out with no medication.
次要结局
- Improved Sleep Scores(Baseline and week 2 through week 12)
研究者
Ann L. Silverman
DIRECTOR OF GI RESEARCH
Henry Ford Health System