Functional Constipation (FC)
Conditions
Interventions
Product Name: Linaclotide
Product Code: A06AX04
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
Allergan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant weighs = 10 kg at the time the parent/guardian/legally authorized representative (LAR) has provided signed consent Participant meets modified Rome III criteria for FC: For at least 2 months before Screening (Visit 1) (for participants aged = 4 years old), or for at least 1 month before Screening (Visit 1) (for participants aged =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For participants aged = 4 years old: Participant meets Rome III criteria for Child/Adolescent IBS: At least once per week for at least 2 months before Screening (Visit 1), the participant has experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time: -Improvement with defecation -Onset associated with a change in frequency of stool -Onset associated with a change in form (appearance) of stool Participant has required manual dis-impaction any time prior to randomization or dis-impaction during in-patient hospitalization within 1 year prior to randomization 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 Participant has had surgery that meets any of the following criteria: -Surgery to remove a segment of the GI tract at any time before Screening (Visit 1) -Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit -An appendectomy or cholecystectomy during the 60 days before Screening (Visit 1) -Other major surgery during the 30 days before Screening (Visit 1) Participant has a mechanical bowel obstruction or pseudo-obstruction. Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class Participant has any of the following conditions: -Celiac disease, or positive serological test for celiac disease or the condition is suspected but has not been ruled out by endoscopic biopsy -Cystic fibrosis -Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to Screening (Visit 1) -Down's syndrome or any other chromosomal disorder -Active anal fissure (ie, participant reports having streaks of blood on the stool or on toilet paper and/or pain/crying with bowel movement within 2 weeks prior to Screening). (Note: Anal fissures that have resolved at least 2 weeks prior to screening would not be exclusionary.) However, if in the investigator's opinion, an anal fissure(s) may be the primary cause of participant's modified Rome III FC criteria, the participant would not be eligible to participate in the study. -Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus) -Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies) -Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma) -Lead toxicity, hypercalcemia -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 and completion of the daily eDiary or other study-related questionnaires (Note: Participants are excluded if the person who will be completing the daily eDiary or other study-related questionnaires meets this criterion.) -Inflammatory bowel disease -Childhood functional abdominal pain syndrome -Childhood functional abdominal pain -Poorly treated or p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation;Secondary Objective: Not applicable;Primary end point(s): Change from baseline in 4-week overall spontaneous bowel movement (SBM) frequency rate (SBMs/week) during the Study Intervention Period of each cohort [ Time Frame: 29 Days ] Change from baseline in 4-week stool consistency reported by the caregiver during the Study Intervention Period of each cohort [ Time Frame: 29 Days ] Change from baseline in 4-week straining reported by the caregiver during the Study Intervention Period of each cohort [ Time Frame: 29 Days ] Proportion of days with fecal incontinence during the Study Intervention Period (for participants who have acquired toileting skills during the daytime and nighttime or acquired toileting skills during daytime only) within each cohort [ Time Frame: 29 Days ];Timepoint(s) of evaluation of this end point: 29 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United States
Contacts
Public ContactTherapeutic Area, Head
Allergan
Outcome results
None listed