NL-OMON41259已完成3 期
A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged * 6 Years to < 18 Years with Functional Constipation - Lubiprostone for the treatment of paediatric functional constipation
Sucampo AG0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 2 至 17（—）
入选标准
- •Written informed consent obtained from subject or parent/legal guardian (and assent from subject where applicable).
- •2. Subject is at least 6 years of age but less than 18 years of age at the time of randomisation.
- •3. Subject is capable of and willing to swallow capsules.
- •4. Subject fulfills the modified Rome III Diagnostic Criteria for Childhood Functional Constipation (Child/Adolescent; Section H3a) as follows:
- •Must include two or more of the following in a child with a developmental age of at least 4 years*: with insufficient criteria for diagnosis of irritable bowel syndrome (IBS)*:
- •* Two or fewer defecations in the toilet per week
- •* At least one episode of faecal incontinence per week
- •* History of retentive posturing or excessive volitional stool retention
- •* History of painful or hard bowel movements
- •* Presence of a large faecal mass in the rectum
- •* History of large diameter stools which may obstruct the toilet
- •* Criteria fulfilled at least once per week for at least 2 months prior to diagnosis.
- •5. If subject is taking a concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility, he/she must discontinue use at the time of the Screening Visit (Visit 1); these medications include:
- •a. Cholinesterase inhibitors; anti-spasmodic, anti-diarrheal, anti-constipation, or prokinetic agents; laxative agents (e.g., PEG 3350), including homeopathic remedies;
- •b. Tricyclic antidepressants; and/or c. Any medication, at the discretion of the Investigator, known to cause constipation or constipation-related symptoms.
- •Any medication, at the discretion of the Investigator, known to relieve or cause constipation or constipation-related symptoms, and which the Investigator, based on the medical history of the subject, suspects to be a contributing factor to the patient*s chronic constipation, or may otherwise confound the evaluation of treatment response.
- •Exceptions: Treatment with anticholinergic agents, SSRIs, SNRIs, or MAO inhibitors is allowed if a stable dose has been used for at least 30 days prior to the Screening Visit and not likely to change during the study.
- •6. Subject (and, if necessary, parent/legal guardian) must be willing and able to use or administer recommended (rectal and/or oral) rescue medications if needed.
- •7. If subject is taking a fibre supplement (e.g., Metamucil®, PerDiem®, Fybogel), usage must have been at a stable dose and schedule for at least 30 days prior to the Screening Visit (Visit 1) and not likely to change during the study.
- •8. Subject and his/her parent/legal guardian must be willing and able to fill out his/her own diary.
- •9. Subject daily diary is at least 70% compliant for evening/end-of-day assessments during the Screening period.
- •10. Subject daily diary indicates an average of less than 3 spontaneous bowel movements (SBMs) per week during the Screening period.
- •11. Subject has at least one of the following for at least 25% of SBMs during each week of the screening period (as reported in the daily diary):
- •* Modified Bristol Stool Scale Type 1 or 2; and/or
- •* Some to extreme straining associated with SBMs.
- •Note: For subjects with no reported SBMs during the Screening Period, it is not necessary to meet criteria for bowel movement characteristics, e.g., hard or very hard stools.;All study subjects who are 6-9 or 14-17 years old and meet the additional DXA evaluation sub-study entry c
排除标准
- •1. Subject*s constipation is known to be attributed to any of the following:
- •a. Physical/Mental/Cognitive * any condition, other than functional constipation, that in the Investigator*s opinion would interfere with meaningful study participation or evaluation.
- •b. Anatomic * associated with a mechanical bowel obstruction (tumour, hernia, obstructive polyps, etc.), or pseudo-obstruction.
- •c. Neurological * associated with spinal cord disorder, congenital disorder, or Guillain-Barre syndrome.
- •d. Endocrine/Metabolic * associated with hypothyroidism, diabetes, hypercalcaemia, or hypokalaemia.
- •e. Inflammatory bowel disease (e.g., Crohn*s disease, ulcerative colitis, celiac disease).
- •f. Medication * associated with the use of medication known to cause constipation.
- •2. Subject is a candidate for, or undergone abdominal surgery including bowel resection, colectomy, gastric bypass surgery (exceptions: appendectomy, cholecystectomy, benign polypectomy and inguinal hernia).
- •3. Subject has any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.
- •4. Subject has Hirschsprung*s disease.
- •5. Subject reports episodes of faecal incontinence that are not associated with retention of stool (e.g., non-retentive faecal incontinence as defined by the Rome III Diagnostic Criteria).
- •6. Subject has current evidence of untreated faecal impaction at the time of screening.
- •7. Subject has experienced an unexplained significant weight loss.
- •8. Subject has a medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
- •9. Subject has an uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease, which the Investigator feels is clinically significant and would limit the subject*s ability to participate in the trial.
- •10. Subject is currently using an indwelling peritoneal catheter.
- •11. Subject has impaired renal function identified at the Screening Visit (i.e., serum creatinine concentration > 1.5 times the median of normal range).
- •12. Subject has abnormal laboratory test (haematology, urinalysis, or blood chemistry), which in the Investigator*s opinion is clinically significant, unexplained, and would limit the subject*s ability to participate in the trial.
- •13. Subject has current evidence of, or has been treated for, cancer within the past 5 years.
- •14. Subject (female of childbearing potential) has a positive pregnancy test, refuses/unwilling to undergo pregnancy testing, and/or does not agree to use protocol-specified contraceptive for the duration of the study.
- •15. Subject or parent/legal guardian demonstrates a potential for non-compliance with study protocol (i.e., dosing schedule, visit schedule, diary completion, or study procedures).
- •16. Subject has received an investigational medication within 30 days prior to the Screening Visit (Visit 1), or plans to participate in another clinical trial during the study period.
- •17. Subject has received AMITIZA, lubiprostone, SPI-0211, or RU-0211 at any time prior to participation in this study.;Exclusion Criteria*:
- •1. Subject has serum 25(OH) vitamin D level <20 ng/mL at Screening.
- •2. Subject has a history of bone disorders (e.g., rickets, osteogenesis imperfecta, rheumatoid arthritis, severe scoliosis), back surgery/injuries, endocrine disorders, anorexia nervosa,
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