EUCTR2005-001725-28-AT进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Long-Term Safety of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults taking Opioid Therapy for Persistent Non-Cancer Pain
GlaxoSmithKline R & D Limited0 个研究点目标入组 750 人开始时间: 2005年8月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Those who understand the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities.
- •2. Those who are a male or female aged 18 years or older at the time of the Screening Visit.
- •3. Those who are able to eat, drink, and take and hold down oral medications.
- •4. Those who are taking routine scheduled maintenance opioid therapy that meets all of the following criteria:
- •a. The maintenance opioid therapy is being taken for the indication of persistent non-cancer pain
- •b. The maintenance opioid therapy is comprised of one or more full opioid agonists
- •c. The maintenance opioid therapy has been dosed for at least one month prior to the Screening Visit and is expected to continue to be dosed for the duration of the study.
- •d. The maintenance opioid therapy route(s) of administration is enteral (oral, transmucosal, sublingual), parenteral infusion (intravenous, subcutaneous, intramuscular), transdermal, or rectal. Parenteral administration via patient-controlled analgesia (PCA) pump and intrathecal administration via pump are permitted, but only under certain circumstances.
- •5. Those who meet the protocol-definition of OBD
- •6. Those who in the investigators opinion, have bowel dysfunction that is predominantly resulting from the use of opioids
- •7. Those who are able and willing to refrain from using prophylactic laxatives and stool softeners from the Screening Visit to the Follow-Up Visit
- •8. Those who are able and willing to refrain from facilitating defecation via manual maneuvers throughout the study
- •9. Those who are able and willing to return for all scheduled visits, is literate and is capable of completing the paper questionnaires
- •10. Those who are ambulatory to the extent that they are capable of self-care and voluntary laxation.
- •11. If female, then the subject is currently either of:
- •a. non-childbearing potential, OR
- •b. child-bearing potential, has a negative urine B-hCG test at the Screening Visit (prior to investigational product administration), and agrees to use acceptable contraception throughout the study until the clinic follow-up 14 days after the last dose of investigational product.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant, lactating, or planning to become pregnant during the study.
- •2. Have (1) participated in another trial with an investigational drug within 30 days prior to the Screening Visit or (2) been randomized to investigational product in this study (SB-767905/014) anytime in the past, or (3) discontinued early from either phase 3 treatment OBD efficacy study (SB-767905/012 or SB-767905/013)
- •3. Taking opioids for cancer-related pain or for the management of drug addiction.
- •4. Taking any mixed agonist/antagonist opioid analgesics .
- •5. Have severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation.
- •6. Have GI or pelvic disorders known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction.
- •7. Currently taking antidiarrheals (e.g., loperamide), has an incidence of diarrhea or loose stools in the 2 weeks prior to the Screening Visit or a history of intermittent diarrhea or loose stools.
- •8. Has, in the investigators opinion, an uncontrolled systemic disease (e.g., hepatic, cardiovascular, renal, pulmonary, autoimmune, endocrine, metabolic, gastrointestinal, hematologic, or neurologic) that would contraindicate participation in this study.
- •9. Have current evidence of, or has been treated for a malignancy within the past five years (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected).
- •10. Have clinically significant laboratory abnormalities prior to randomization that are suggestive of hepatic dysfunction, viral hepatitis, renal impairment or suggestive of any other condition that would contraindicate participation in this study
- •11. Have a history within the past 2 years of alcohol, substance abuse, or psychiatric disorder likely to confound the assessment of gastrointestinal function.
- •12. Currently taking a concomitant medication or has any other known condition or physical examination finding that could contraindicate participation in this study.
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectioCrohn’s DiseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2019-000886-19-ATMillennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)96
进行中（未招募）
1 期
An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.Myasthenia GravisEUCTR2018-002132-25-NLargenx BVBA150
进行中（未招募）
1 期
A Phase 2b study to demonstrate the safety and efficacy of Tildrakizumab in patients with Active Psoriatic ArthritisMedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000018188Psoriatic ArthritisEUCTR2016-003937-62-HUSUN Pharma Global FZE360
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes MellitusMedDRA version: 14.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2012-002414-39-ITMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.4,202
已完成
2 期
A Study to Evaluate the Safety and Efficacy of Anamorelin HCL in Patients with Non Small Cell Lung CancerCTRI/2011/091/000299Helsinn Therapeutics US Inc228