NCT00755482已完成1 期
Randomised, Placebo Controlled Trial to Examine the Effect of Aquamin F on NSAID Dose Reduction in Subjects With Osteoarthritis of the Knee.
Marigot Ltd.1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- WOMAC scores (pain, stiffness, mobility, total score)
研究概览
简要总结
The objective of this trial is to evaluate the effect of Aquamin F versus placebo on NSAID (non-steroidal anti-inflammatory drug) dose reduction in subjects with osteoarthritis of the knee.
Hypothesis 1: After 12 weeks of treatment, subjects taking Aquamin F will use significantly less NSAID medications for symptoms of osteoarthritis versus placebo alone.
Hypothesis 2: No significant differences will be seen for adverse events between the subjects taking Aquamin F or placebo.
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
- Double
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 35 to 75, male or female
- •Subjects diagnosed with symptomatic moderate to severe osteoarthritis of the knee according to the modified criteria of the American College of Rheumatology 17,18
- •Subjects who present with osteoarthritis of the knee as judged by symptoms and disabilities detectable through published, validated questionnaires or previous diagnosis by a physician
- •subjects who are symptomatic with daily or near daily pain and stiffness from osteoarthritis
- •subjects who are taking non-steroidal anti-inflammatory drugs (NSAIDs) prior to study enrollment
- •subjects who are willing to stop NSAIDS and use acetaminophen for pain management during the trial
- •subjects with screening WOMAC osteoarthritis index total score (transformed score) of not more than 75
- •subjects with ability to comprehend and complete the questionnaires and forms
- •subjects whose schedules permit clinical evaluations every four weeks
- •subjects who are willing to stop taking calcium supplements, if any and to restrict consumption of high calcium food to 600mg (two dairy servings) per day
- •subjects with a high probability of compliance with study procedures and test article consumption
- •subjects willing and able to follow protocol guidelines and schedules and complete diaries
- •subjects who are likely to abstain from taking unathorized supplements or participating in any other clinical trial or experimental treatment during this trial
- •subjects with normal gastrointestinal digestion and absorption
排除标准
- •subjects who have a history of inflammatory arthritis, gout, pseudogout, Paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or HIV infection
- •subjects who are non-ambulatory or bedridden due to osteoarthritis
- •subjects who are dependent on prescription drugs to control pain
- •subjects on any other clinical trial or experimental treatment in the past 3 months
- •subjects who are pregnant, lactating or at risk of becoming pregnant
- •subjects who have received : intramuscular corticosteroid injection or systemic corticosteroid administration within 4 weeks prior to study enrollment, intra-articular corticosteroid injection within 2 months prior to study enrollment or intra-articular hyaluronic acid injection within 4 months prior to study enrollment.
研究组 & 干预措施
2
Placebo Comparator
Subjects were given a maltodextran placebo
干预措施: Placebo (maltodextran) (Drug)
1
Active Comparator
Subjects were given Aquamin F
干预措施: Aquamin F (Drug)
结局指标
主要结局
WOMAC scores (pain, stiffness, mobility, total score)
6 minute walking distances
Active and Passive range of motion (goniometer measurements)
NSAID usage
Rescue medication (acetaminophen) usage
次要结局
- DXA scans for bone mineral density
- CRP levels
- Lipid profiles
- the safety/toxicology measurements including a chemistry profile (including serum calcium)
- complete blood counts
- adverse events
研究者
研究点 (1)
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