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Functional Constipation: Linaclotide versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, with Functional Constipation (FC)
EU CTIS ID: 2022-501946-31-00
What this study is testing
Part 1: to evaluate the safety and efficacy of 12 weeks of linaclotide therapy in comparison with placebo in pediatric subjects aged 2 to 5 years who meet modified Rome IV criteria for childhood FC. Part 2: to assess the long-term safety of linaclotide administered to subjects with pediatric FC who have completed study intervention in Part 1 of this study or completed Study LIN-MD-67.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects must be ages 24 months to 5 years and 11 months (inclusive) at the time the caregiver/parent/guardian/LAR has provided signed consent in alignment with local requirements.
- Subject does not have any condition or clinically significant findings on a physical examination, vital sign assessment, ECG, or clinical laboratory tests at Screening (Visit 1), as determined by the investigator, based on consideration of whether the finding could represent a safety concern or a condition that would be exclusionary, could prevent the subject from performing any protocol assessments, or could confound study assessments.
- Subject meets modified Rome IV criteria for FC: For at least 1 month before Screening (Visit 1), the subject 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) per week.
- Caregiver/parent/guardian/LAR is willing to discontinue any laxatives used before the Preintervention Visit (Visit 2) in favor of the protocol-permitted rescue medicine.
- Based on the eDiary, the subject has an average ≤ 2 SBMs per week during the 14 days before the randomization day and up to the randomization (including the eDiary assessments reported before administration of first dose of double-blind study intervention on the randomization day). An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM.
You likely can't join if
- Subjects with conditions that could interfere with drug absorption including, but not limited to, short bowel syndrome.
- Subjects with history of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.
- Subjects with history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
- Subjects with condition of unexplained and clinically significant alarm symptoms (lower gastrointestinal [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.
- Subjects with history of known or suspected mechanical bowel obstruction or pseudo-obstruction.
- Subject did not use a protocol-specified prohibited medicine before the start of the Preintervention Period or failed to meet the stable-dose requirements of certain medications.
See the full eligibility criteria
Who can join
- Subjects must be ages 24 months to 5 years and 11 months (inclusive) at the time the caregiver/parent/guardian/LAR has provided signed consent in alignment with local requirements.
- Subject does not have any condition or clinically significant findings on a physical examination, vital sign assessment, ECG, or clinical laboratory tests at Screening (Visit 1), as determined by the investigator, based on consideration of whether the finding could represent a safety concern or a condition that would be exclusionary, could prevent the subject from performing any protocol assessments, or could confound study assessments.
- Subject meets modified Rome IV criteria for FC: For at least 1 month before Screening (Visit 1), the subject 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) per week.
- Caregiver/parent/guardian/LAR is willing to discontinue any laxatives used before the Preintervention Visit (Visit 2) in favor of the protocol-permitted rescue medicine.
- Based on the eDiary, the subject has an average ≤ 2 SBMs per week during the 14 days before the randomization day and up to the randomization (including the eDiary assessments reported before administration of first dose of double-blind study intervention on the randomization day). An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM.
What rules you out
- Subjects with conditions that could interfere with drug absorption including, but not limited to, short bowel syndrome.
- Subjects with history of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.
- Subjects with history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
- Subjects with condition of unexplained and clinically significant alarm symptoms (lower gastrointestinal [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.
- Subjects with history of known or suspected mechanical bowel obstruction or pseudo-obstruction.
- Subject did not use a protocol-specified prohibited medicine before the start of the Preintervention Period or failed to meet the stable-dose requirements of certain medications.
- Subject must not have been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
- Subject must not have any planned or ongoing toilet training at any time in Part 1. Subjects may start toilet training at any time during Part 2. Toilet training is defined as the process of training a child to recognize their body signals for the need to urinate and/or have a bowel movement, to control the urination and/or bowel movement and to use the toilet. Children who are fully toilet trained or who have not yet started the process are eligible to participate.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.