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)
- Conditions
- Functional constipationIrritable Bowel Syndrome10002112
- Registration Number
- NL-OMON52547
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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).
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>No endpoints are specified for this long-term safety study. The safety<br /><br>assessments will include monitoring of adverse events (AEs), clinical<br /><br>laboratory assessments (clinical chemistry, complete blood count [CBC],<br /><br>urinalysis), vital sign measurements (including postural vital signs),<br /><br>electrocardiograms (ECGs), physical examinations, height, and weight.</p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>