NL-OMON51845招募中3 期
A randomized, double-blind, placebo-controlled, Phase III trial to evaluate the efficacy and safety of intra-articular injections of RTX-GRT7039 in adult subjects with pain associated with osteoarthritis of the knee - Grunenthal KF7039-01 (RTX GRT7039); 0389/0073
Grunenthal0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •>= 18 years of age at the screening visit.
- •Body Mass Index (BMI) <= 40.0 kg/m2.
- •Diagnosis of osteoarthritis of the knee based on American College of
- •Rheumatology criteria and functional capacity class of I-III.
- •Moderate to severe osteoarthritis at baseline.
- •Documented history indicating that subject has insufficient pain relief with
- •optimal standard of care (SoC).
- •The investigator does not consider that any additional benefit can reasonably
- •be expected from further adjustments to the patient's pain treatment.
- •For the list of complete inclusion criteria refer to the protocol.
排除标准
- •The subject had an intra-articular injection of either corticosteroid or
- •intra-articular visco-supplementation (i.e., hyaluronic acid) into the index
- •knee within 3 months.
- •The subject had an injection of platelet-rich plasma into the index knee
- •within 6 months.
- •The subject applied topical capsaicin on the index knee within 3 months.
- •Pre-existing rapidly progressing osteoarthritis (RPOA) Type I or Type II,
- •osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, or
- •the subject has knee pain attributable to disease other than osteoarthritis.
- •Other conditions that could confound discrimination of pain assessment in the
- •index knee.
- •Clinically significant disease(s) or condition(s) that may affect efficacy or
- •safety assessments, or any other reason which, in the investigator's opinion,
- •may preclude the subject's participation in the full duration of the trial.
- •History of severe allergic or anaphylactic reactions.
- •History of significant trauma or surgery, or surgery planned during the trial
- •period, related to the knee.
- •For the complete list of exclusion criteria refer to the protocol.
研究者
相似试验
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in subjects with chronic genotype 1 hepatitis C infection who failed prior pegylated interferon plus ribavirin treatment. - REALIZEEUCTR2008-000533-22-ATTibotec BVBA650
进行中（未招募）
1 期
Comparison of a single RTX-GRT7039 and placebo intra-articular injection for pain associated with osteoarthritis of the knee.EUCTR2021-005020-38-ESGrünenthal GmbH450
招募中
1 期
A randomized, double-blind, placebo-controlled, Phase 2b trial of GH001 in patients with treatment resistant depressioTreatment-resistant depression (TRD)MedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2022-000574-26-IEGH Research Ireland Limited80
招募中
3 期
Comparison of RTX-GRT7039 and placebo injections for pain associated with osteoarthritis of the knee.Moderate to severe pain associated with osteoarthritis of the kneeJPRN-jRCT2031220354ange Bernd, MD, MSc, Medical Lead90
已完成
3 期
A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in subjects with chronic genotype 1 hepatitis C infection who failed prior pegylated interferon plus ribavirin treatment.NL-OMON32876Janssen-Cilag18