NL-OMON52547已完成3 期
A Phase 3, Open-label, Long-term Safety Study of Oral Linaclotide Administered to Pediatric Participants with Functional Constipation (FC) or Irritable Bowel Syndrome with Constipation (IBS-C) - LIN-MD-66
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. Participant weighs >= 18 kg at the time the parent/guardian/LAR and/or
- •caregiver has provided signed consent.
- •2. Female participants who have had their first menstrual period and are
- •sexually active must agree to use a reliable form of contraception.
- •3. Male or female participants must be 6 to 17 years of age (inclusive), at the
- •time the parent/guardian/LAR and/or caregiver provides written informed consent
- •and the participant must provide assent before the initiation of any
- •study-specific procedures.
- •4. Participants must have completed study intervention in their lead-in study
- •as defined in Section 4.1 of protocol.
- •5. Female participants of childbearing potential must have a negative pregnancy
- •test at both Screening (Visit 1) and at Study Day 1 (Visit 2).
- •6. Participants who turn 18 years of age prior to enrollment must provide
- •consent for the study.
- •7. Female participants of childbearing potential must have a negative serum
- •pregnancy test at the Screening Visit (Visit 1) and negative urine pregnancy
- •test prior to the first dose on the Day 1 Visit (Visit 2).
排除标准
- •1. Participant has an unresolved AE or a clinically significant finding on
- •aphysical examination along with ECG or clinical laboratory tests that; in the
- •opinion of the investigator, 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.
- •2. Participant has a known allergy or sensitivity to the study interventionor
- •its components or other medications in the same drug class.
- •3. Participant is not willing or able to abide by the restrictions regarding
- •concomitant medicine use defined in Section 6.5.
- •4. Participant received an investigational drug, other than linaclotide, during
- •the 30 days before the Screening Visit (Visit 1) or is planning to receive an
- •investigational drug (other than that administered during this study) or use an
- •investigational device at any time during the study.
- •5. Female participants who are currently pregnant or nursing, or plan to become
- •pregnant or nurse during the clinical study.
- •6. Participant has fecal impaction at the Day 1 Visit (Visit 2).
- •7. Participant has required manual disimpaction any time prior to study
- •intervention.
- •8. Participant has any of the following conditions:
- •a) Down's syndrome or any other chromosomal disorder
- •b) Anatomic malformations (eg, imperforate anus, anal stenosis, anterior
- •displaced anus)
- •c) Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral
- •myopathies, visceral neuropathies)
- •d) Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis,
- •tethered cord, spinal cord trauma).
- •e) 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 by the participant.
- •9. Participant has an acute or chronic condition that, in the
- •investigator'sopinion, would limit the participants' ability to complete or
- •participate in this clinical study.
- •10. The participant has a condition or is in a situation which, in the
- •investigator's opinion, may put the participant at significant risk, may
- •confound the study results, or may interfere significantly with the
- •participant's participation in the study.
- •For further exclusion criteria, please refer to the protocol section 5.2
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