NCT00803023已完成3 期
Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 32
- 主要终点
- Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
研究概览
简要总结
To compare the safety and tolerability of sodium oxybate given as a combination of an oral solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Subject is able to understand the written informed consent
- •Subject is 18 years of age or older.
- •Subject meets the ACR criteria for fibromyalgia
- •Subject is willing to discontinue prohibited by the protocol
- •Subject agrees to use only non-sedating over-the-counter (OTC)medication
- •Subject is willing to abstain from the ingestion of alcohol for the duration of the trial.
排除标准
- •Subject has protocol prohibited medical & psychiatric conditions that would exclude subject
- •Subject has a current or past history of a substance use disorder including alcohol abuse
- •Subject has a clinically significant history of seizure disorder either past or present
- •Female subject who is pregnant, nursing or lactating.
- •Subject is diagnosed with sleep apnea
- •Subject is unable to discontinue protocol prohibited medications
- •Subject is experiencing fatigue and/or drowsiness/sedation in association with intake of allowed medications.
- •Subject has taken any investigational drug within 5 half-lives of the investigational drug prior to signing the informed consent form.
- •Subject has an allergic reaction to GHB or sodium oxybate or any of its constituents (e.g. malic acid).
- •Subject is on a sodium-restricted diet.
- •Subject has abnormal liver function test or other abnormal lab values
- •Subject has an occupation that requires variable shift work or routine night shifts or cannot routinely spend at least 6 hours per night in bed.
- •Subject has any other problems that, in the investigator's opinion, would preclude the subject's participation and completion of this trial or compromise reliable representation of subjective symptoms.
- •Subject has been randomized into a previous Xyrem (sodium oxybate) clinical trial.
研究组 & 干预措施
1
Experimental
Sodium Oxybate Oral Solution (4.5 grams)
干预措施: Sodium Oxybate (Drug)
2
Experimental
Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams)
干预措施: Sodium Oxybate & 6 Tablets (Drug)
3
Experimental
Sodium Oxybate Oral Solution (6 grams)
干预措施: Sodium Oxybate Oral Solution (6 grams) (Drug)
4
Experimental
Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams)
干预措施: Sodium Oxybate & 8 Tablets (Drug)
结局指标
主要结局
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
时间窗: 4 weeks
次要结局
- Tolerability Assessed by Adverse Events(4 weeks)
研究者
研究点 (32)
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