Functional Constipation (FC) Irritable bowel syndrome with constipation (IBS-C) MedDRA version: 20.0 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: LLT Classification code 10066868 Term: Constipation predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Allergan Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety of Linaclotide in pediatric participants with FC (total exposure with linaclotide for 24 weeks) who have completed study intervention in the study LIN-MD-64 or IBS-C (total exposure with linaclotide for 52 weeks) who have completed study intervention in Study LIN-MD-62, LIN-MD-63, or LIN-MD-64.;Secondary Objective: Not applicable;Primary end point(s): No endpoints are specified for this long-term safety study.;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Belgium, Bulgaria, Canada, Estonia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Serbia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactCTRG
Allergan Ltd
Outcome results
None listed