Frontier Clinical Research, LLC | Smithfield , PA
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About
LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants (6-17 years of age) with FC or IBS-C who completed study intervention in studies LIN-MD-62, LIN-MD-63, orLIN-MD-64 based on the individual study criteria.
Enrollment
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Inclusion criteria
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:
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).
LIN-MD-63 completers only: Participants meet Rome III criteria for child/adolescent IBS: At least once per week for at least 2 months before the LIN-MD-66 Screening Visit (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:
Participants meet modified Rome III criteria for child/adolescent FC: For at least 2 months before the LIN-MD-66 Screening Visit (Visit 1), the participant has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week. In addition, at least once per week, participant meets 1 or more of the following:
Exclusion criteria
Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class.
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.
Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
Participant has required manual disimpaction any time prior to study intervention or disimpaction during in-patient hospitalization within 1 year prior to study intervention.
Participant has any of the following conditions:
Participant has a mechanical bowel obstruction or pseudo-obstruction.
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 an active anal fissure (Note: history of anal fissure is not an exclusion).
Participant has had surgery that meets any of the following criteria:
Participant is receiving enteral tube feeding
Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids will be excluded from study participation.
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:
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:
a) Improvement with defecation
b) Onset associated with a change in the frequency of stool
c) Onset associated with a change in form (appearance) of stool
a) Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy
b) Cystic fibrosis
c) Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening (Visit 1)
d) Lead toxicity, hypercalcemia
e) Inflammatory bowel disease
f) Childhood functional abdominal pain syndrome
g) Childhood functional abdominal pain
h) Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study
i) Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study
j) History of cancer other than treated basal cell carcinoma of the skin. (Note: Participants with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit. A complete remission is defined as the disappearance of all signs of cancer in response to treatment.)
k) History of diabetic neuropathy
Primary purpose
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389 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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