NL-OMON52398已完成3 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) - Allergan LIN-MD-64
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
- 2 至 17（—）
入选标准
- •1. Age and Weight
- •1.01. Male 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
- •1.02. Participant weighs >=18 kg at the time the participant provides assent and
- •the parent/guardian/LAR has provided signed consent
- •2. Type of Participant and Disease Characteristics
- •2.01. Participants who meet the modified Rome III criteria for Child/Adolescent
- •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
- •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
- •2.02. Participant is willing to discontinue any laxatives used before the
- •Preintervention Visit in favor of the protocol- permitted rescue medicine.
- •2.03. Participant 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
- •2.04. Participant 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
- •3.01.Female 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.
- •3.02. Female 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.
- •4. Informed Consent
- •4.01. Participant 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
- •5.01. Participant must have acquired toilet training skills
排除标准
- •1. Medical Conditions
- •1.01. Participant 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
- •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
- •1.02. Participant 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)
- •1.03. Participant has a history of non-retentive fecal incontinence
- •1.04. Participant has (a) fecal impaction at Visit 2 and has failed outpatient
- •clean-out during the Screening Period (b) fecal impaction at Visit 3.
- •1.05. Participant has required manual disimpaction any time prior to
- •randomization
- •1.06. Participant 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
- •1.07. Participant has clinically significant findings on a physical
- •examination, vital sign assesment, 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.
- •1.08. Participant has a history of drug or alcohol abuse.
- •1.09. Participant 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
- 另有 2 项未显示
研究者
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