EUCTR2019-001955-38-NL进行中（未招募）1 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) - Long-term Safety of Linaclotide in Pediatric Participants with FC or IBS-C.
Allergan Ltd0 个研究点目标入组 120 人开始时间: 2021年4月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •5.1.1. General Inclusion Criteria (All Participants)
- •1.01 Participant weighs = 18 kg at the time the parent/guardian/LAR and/or caregiver has provided signed consent.
- •1.02 Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception.
- •1.03 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.
- •1.04 Participants must have completed study intervention in their lead-in study.
- •1.05 Female participants of childbearing potential must have a negative pregnancy test at both Screening (Visit 1) and at Study Day 1 (Visit 2)
- •5.1.2. Inclusion Criteria for Phase 3 LIN-MD-64 Completers and Phase 2 LIN-MD-63 Completers Who Enroll in LIN-MD-66 Within = 28 Days From Last Study Intervention
- •2.01 Participants who turn 18 years of age prior to enrollment must provide consent for the study.
- •5.1.3. Inclusion Criteria for Phase 2 LIN-MD-62 or Phase 2 LIN-MD-63 and Phase 3 LIN-MD-64 Completers Who Enroll in LIN-MD-66 After > 28 Days From Last Study Intervention
- •3.01 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).
- •3.02 This criterion has been removed
- •3.03 This criterion has been removed
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •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
- •5.2.1. General Exclusion Criteria (All Participants)
- •1.01 Participant has an unresolved AE or a clinically significant finding on a physical examination or vital sign assessment along with ECG or clinical laboratory tests (if results are available by the time of enrollment) 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. Clinical laboratory levels that will be measured are summarized in Table 10-1.
- •1.02 Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class.
- •1.03 Participant is not willing or able to abide by the restrictions regarding concomitant medicine use defined in Section 6.5.
- •1.04 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.
- •1.05 Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
- •1.06 Participant has fecal impaction at the Day 1 Visit (Visit 2).
- •1.07 Participant has required manual disimpaction any time prior to study intervention.
- •1.08 Participant has any of the conditions described in protocol points a/b/c/d/e.
- •1.09 Participant has an acute or chronic condition that, in the investigator's opinion, would limit the participants’ ability to complete or participate in this clinical study.
- •1.10 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.
- •1.11 Participant has a known or suspected mechanical bowel obstruction or pseudoobstruction.
- •1.12 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.
- •1.13 Participant has an active anal fissure (Note: history of anal fissure is not an exclusion).
- •1.14 Participant has had surgery that meets any of the criteria defined in protocol points a/b/c/d.
- •1.15 This criterion has been removed
- •1.16 This criterion has been removed
- •1.17 Participants with hypothyroidism who have been treated with a stable dose of thyroid hormone in the last three months prior to Screening (Visit 1) must have their history confirmed by both a medical record and a recent (within 2 months of Screening Visit) blood sample. Thyroid function tests, if not recent, must be checked during screening to trial for fT3, fT4 and TSH ,+/- TPO antibodies) prior to the study treatment.
- •5.2.2. Exclusion Criteria for LIN-MD-62, LIN-MD-63 and LIN-MD-64 Completers Who Enroll in LIN-MD-66 > 28 Days From Last Study Intervention
- •2.01 Participant has a history of nonretentive fecal incontinence
- •2.02 This criterion has been removed
- •2.03 Participant has a history of drug or alcohol abuse
- •2.04 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 biop
研究者
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