Functional constipation Irritable Bowel Syndrome
Conditions
Interventions
Participants will receive open-label linaclotide 72 µg or 145 µg once daily for
24 weeks (FC participants) or open-label linaclotide 72 µg, 145 µg, or 290 µg
once daily for 52 weeks (IBS-C participa
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No endpoints are specified for this long-term safety study. The safety assessments will include monitoring of adverse events (AEs), clinical laboratory assessments (clinical chemistry, complete blood count [CBC], urinalysis), vital sign measurements (including postural vital signs), electrocardiograms (ECGs), physical examinations, height, and weight. | — |
Countries
Netherlands
Outcome results
None listed