EUCTR2019-001500-38-NL进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of Linaclotide Administered Orally to Children, Ages 6 to 17 Years, With Functional Constipation (FC) - Linaclotide Safety and Efficacy Functional Constipation (FC),
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 326
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.Age and Weight
- •1.01Male and female participants must be ages 6 to 17 years, (inclusive) at the time the participant provides assent for the study and parent/guardian/legally authorized representative (LAR) has provided signed consent
- •1.02: Participant weighs =18 kg at the time the participant provides assent and the parent/guardian/LAR has provided signed consent
- •2.01: Participants who meet the modified Rome III criteria for Child/Adolescent FC. For at least 2 months before the Screening Visit, the participant has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week.
- •In addition, participant meets one or more of the following criteria at least once per week for at least 2 months before the screening visit:
- •- History of retentive posturing or excessive volitional stool retention
- •- History of painful or hard BMs
- •- History of large diameter stools that may obstruct the toilet
- •- Presence of a large fecal mass in the rectum
- •- At least 1 episode of fecal incontinence per week
- •2.02Participant is willing to discontinue any laxatives used before the Preintervention Visit in favor of the protocol- permitted rescue medicine.
- •2.03Participant has an average of fewer than 3 SBMs per week during the 14 days before the randomization day and up to the randomization (including the morning eDiary assessments reported before administration of first dose of double-blind study intervention on the randomization day). An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM
- •2.04Participant or parent/guardian/LAR or caregiver is compliant with eDiary requirements by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit
- •3.Contraceptives
- •3.01Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Randomization Visit prior to dosing
- •3.02Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception. Reliable contraception is defined in Section 10.7 Appendix 7.
- •4.Informed Consent
- •4.01Participant must provide written or verbal informed assent and the parent/guardian/LAR and caregiver must provide written informed consent before the initiation of any study-specific procedures
- •4.02: Participant is able to read and/or understand the assessments in the eDiary device. If the participant is 6 to 11 years of age and does not meet this criterion, the interviewer-administered version of the eDiary must be used and the parent/guardian/LAR or caregiver who will be administering the interviewer- administered version of the eDiary must undergo training
- •5.01Participant must have acquired toilet training skills
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 326
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Medical Conditions
- •1.01Participant meets Rome III criteria for Child/Adolescent IBS: At least once per week for at least 2 months before the Screening Visit, the participant has experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:
- •a.Improvement with defecation
- •b.Onset associated with a change in frequency of stool
- •c.Onset associated with a change in form (appearance) of stool
- •1.02Participant reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization (including the morning eDiary assessments reported before administration of first dose of double-blind study intervention on the randomization day)
- •1.03Participant has a history of non-retentive fecal incontinence
- •1.04Participant has fecal impaction at Visit 2 and has failed outpatient clean-out during the Screening Period
- •1.05: Participant has required manual disimpaction any time prior to randomization
- •1.06Participant currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], iron deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process
- •1.07Participant has clinically significant findings on a physical examination, ECG, or clinical laboratory test as determined by the investigator based on consideration of whether the finding could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments.
- •1.08Participant has a history of drug or alcohol abuse.
- •1.09Participant has any of the following conditions:
- •a.Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy
- •b.Cystic fibrosis
- •c.Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening Visit
- •d.Down's syndrome or any other chromosomal disorder
- •e.Active anal fissure (Note: History of anal fissure is not an exclusion)
- •f.Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus)
- •g.Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies)
- •h.Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma)
- •i.Lead toxicity, hypercalcemia
- •j.Neurodevelopmental disabilities (early-onset, chronic disorders that share the essential feature of a predominant disturbance in the acquisition of cognitive, motor, language, or social skills, which has a significant and continuing impact on the developmental progress of an individual) producing a cognitive delay that precludes comprehension and completion of the daily eDiary or other study related questionnaires (Note: Participants are excluded if the person who will be completing the daily eDiary or other study-related questionnaires meets this criterion.)
- •k.Inflammatory bowel disease
- •l.Childhood functional abdominal pa
研究者
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