NL-OMON38356招募中3 期
A 12-week, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of prucalopride in subjects with chronic non-cancer pain suffering from opioid induced constipation - A randomised trial in subjects with chronic pain suffering from OIC
Shire-Movetis NV0 个研究点目标入组 23 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
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
- •Main inclusion criteria to be assessed at screening:
- •1. Subject is a male or non-pregnant, non-breastfeeding female out-patient >=18 years of age (no upper age limit).
- •2. Subject has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids; has been on a stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on a stable daily dose of opioids for at least 15 weeks after Visit 1.
- •3. Subject is suffering from OIC (i.e. secondary to chronic opioid use), which is defined as having an average of <=2 SBM/week and one or more of the following symptoms that started after initiating opioids:
- •a. Very hard (little balls) and/or hard stools at least a quarter of the stools.
- •b. Sensation of incomplete evacuation following at least a quarter of the stools.
- •c. Straining at defecation at least a quarter of the time.
- •The above criteria are only applicable for SBMs, i.e. bowel movements
- •not preceded within a period of 24 hours by the intake of a laxative agent
- •or by the use of an enema. Subjects who never have SBMs are considered to be constipated and are eligible for the trial.
- •4. Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule [Dulcolax® (bisacodyl)/ enemas].
- •5. Subject is able and willing to complete the questionnaires (if a validated version in the language of the subject is available) and the e-diary.
- •6. Women of childbearing potential should have a negative serum pregnancy test at Visit 1 (screening) and should use an efficient method of birth control for the duration of the trial and until the first menses after a 30-day period after the last dose of trial medication. They must be on a stable regimen, for at least 1 month, of oral contraceptives, contraceptive implant or depot injection, contraceptive patch, intrauterine device (IUD), condom and spermicidal agent, or diaphragm and spermicidal agent, or agree upon continuous abstinence from heterosexual sexual contact and be willing to continue this contraception.
- •7. Subject voluntarily signed the Informed Consent Form (ICF) in accordance with the regional laws/regulations, before the first trial-related activity.
- •8. Subject is willing to adhere to all trial requirements.;Main inclusion criteria to be assessed at baseline (randomisation):
- •1. Subject has been taken a stable maintenance dose of opioids during the run-in period.
- •2. Subject is constipated, i.e. had an average of <=2 SBM/week during the run-in period.*
- •3. Subject stopped his/her laxative treatment and did not use rescue mediation on more than 75% of days of the run-in period.*
- •4. Subject did not use disallowed medication during the run-in period.
- •* Excluding the first 7 days for subjects using medication influencing bowel habit.
排除标准
- •Main exclusion criteria to be assessed at screening:
- •1. Constipation is thought to be drug-induced (except for opioids).
- •2. Disallowed medication is being used.
- •3. Subject was on chronic therapy for chronic constipation prior to the start of opioid therapy.
- •4. Subject is suffering from secondary causes of chronic constipation.
- •5. Significant history of cancer (i.e. less than 5-year disease-free survival).
- •6. Presence of megacolon/megarectum or diagnosis of pseudo-obstruction.
- •7. Known serious illnesses: clinically significant cardiac, vascular, liver, pulmonary, endocrine, neurological or psychiatric disorders (as evaluated by the Investigator), or metabolic disturbances.
- •8. Known terminal illnesses: anticipated lifespan is shorter than the maximum duration of the trial (i.e. <4 months).
- •9. Any condition that in the opinion of the Investigator would complicate or compromise the trial or the well-being of the subject or evidence of clinically relevant pathology that could interfere with the trial results or put the subject*s safety at risk.
- •10. Serum creatinine concentration of greater than >180 µmol/l or calculated creatinine clearance <=30 ml/min.
- •11. Clinically significant abnormalities of haematology, urinalysis, or blood chemistry as determined by the Investigator.
- •12. Subject is known to have human immunodeficiency virus (HIV) infection or AIDS, hepatitis B or hepatitis C.
- •13. History of alcohol or drug abuse in the previous 6 months.
- •14. Subjects with lactose intolerance from whom it is expected that low doses of lactose can lead to diarrhoea, or a known allergy to ingredients or excipients of the trial medication.
- •15. Use of investigational medication in the 30 days preceding Visit 1 of this trial.
- •16. Subjects who previously used prucalopride
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