--- title: A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide nct_id: NCT05760313 overall_status: COMPLETED phase: PHASE2 sponsor: AbbVie study_type: INTERVENTIONAL primary_condition: Functional Constipation countries: United States, Bulgaria, Croatia, Germany, Hungary, Serbia, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05760313.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05760313" ct_last_update_post_date: 2026-01-06 last_seen_at: "2026-05-12T06:55:04.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide **Official Title:** A Phase 2 Dose Finding Study Evaluating the Safety and Efficacy of Linaclotide in Pediatric Subjects 6 Months to Less Than 2 Years of Age With Functional Constipation (FC). **NCT ID:** [NCT05760313](https://clinicaltrials.gov/study/NCT05760313) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 19 - **Lead Sponsor:** AbbVie - **Collaborators:** Ironwood Pharmaceuticals, Inc. - **Conditions:** Functional Constipation - **Start Date:** 2023-04-27 - **Completion Date:** 2025-06-09 - **CT.gov Last Update:** 2026-01-06 ## Brief Summary Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Up to 30 and at least 18 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at approximately 38 sites worldwide. Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. ## Eligibility - **Minimum age:** 6 Months - **Maximum age:** 23 Months - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Individuals must be 6 months to less than 1 year and 11 months old, at the time the legally authorized representative (LAR)/parent/guardian signs the informed consent in alignment with local requirements. * The LAR/parent/guardian who will be completing the electronic diary (eDiary) is able to read and understand the assessments in the eDiary device and must undergo training. * Participant meets Rome IV criteria for functional constipation (FC): for at least 1 month before Screening (Visit 1), the participant must meet 2 or more of the following: * 2 or fewer defecations per week (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) * History of excessive stool retention * History of painful or hard bowel movements (BMs) * History of large-diameter stools * Presence of a large fecal mass in the rectum * LAR/Parent/Guardian is willing to discontinue any laxatives used before the Preintervention Visit in favor of the protocol-permitted rescue medicine. Exclusion Criteria: * Participant has conditions that could interfere with drug absorption, including, but not limited to, short bowel syndrome. * History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the individual's participation in this study or would make the participant an unsuitable candidate to receive study drug. * Participant has history of: * 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 (investigator has confirmed an active anal fissure and participant reports known anal fissure symptoms \[i.e., streaks of blood on the stool or on diaper or toilet paper and pain/crying with bowel movement within 2 weeks prior to Screening\]). (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 Rome IV FC criteria, the subject would not be eligible to participate in the study. * Anatomic malformations (e.g., imperforate anus, anal stenosis, anterior displaced anus) * Intestinal nerve or muscle disorders (e.g., Hirschprung disease, visceral myopathies, visceral neuropathies) * Neuropathic conditions (e.g., spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma) * Lead toxicity, hypercalcemia * Inflammatory bowel disease * Lactose intolerance that is associated with symptoms which could confound the assessments in this study * History of cancer. (Note: Participants with a history of cancer are allowed provided that the malignancy has been in a complete remission before enrollment/randomization (Visit 3). A complete remission is defined as the disappearance of all signs of cancer in response to treatment) ``` ## Arms - **Part 1, Linaclotide Dose A** (EXPERIMENTAL) — Linaclotide Dose A capsules, mixed with water and administered orally, once daily for 4 weeks - **Part 1, Linaclotide Dose B** (EXPERIMENTAL) — Linaclotide Dose B capsules, mixed with water and administered orally, once daily for 4 weeks - **Part 1, Linaclotide Dose C** (EXPERIMENTAL) — Linaclotide Dose C capsules, mixed with water and administered orally, once daily for 4 weeks - **Part 2, Linaclotide** (EXPERIMENTAL) — Participants will receive Linaclotide capsules mixed with water and administered orally in Part 2 for 4 weeks. - **Part 2, Placebo** (EXPERIMENTAL) — Participants will receive placebo capsules mixed with water and administered orally in Part 2 for 4 weeks. ## Interventions - **Linaclotide** (DRUG) — Capsule; oral - **Placebo** (DRUG) — Capsule; oral ## Primary Outcomes - **Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period** _(time frame: Baseline to Week 4)_ — 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. The caregiver/parent/guardian/legally authorized representative (LAR) will complete the electronic diary (eDiary), providing data for the SBM frequency rate up to the last dose date equivalent to the 4-week SBM frequency rate. - **Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period** _(time frame: Baseline to Week 4)_ — The caregiver/parent/guardian/legally authorized representative (LAR) will rate and record in an eDiary the consistency of the stool for each BM using the Bristol Stool Form 7-point scale in which 1=Separate hard lumps, like nuts (hard to pass); 2=Sausage-shaped, but lumpy; 3=Like a sausage but with cracks on its surface; 4=Like a sausage or snake, smooth and soft; 5=Soft blobs with clear cut edges (easy to pass); 6=Fluffy pieces with ragged edges, a mushy stool; and 7=Watery, no solid pieces, entirely liquid. - **Change From Baseline in Straining During the Study Intervention Period** _(time frame: Baseline to Week 4)_ — Straining for each LAR/parent/guardian/caregiver-observed BM the child passes was collected daily in the eDiary device, using a 4-point scale (0 = No, not at all; 1 = Yes, a little; 2 = Yes, a lot; 3 = I don't know) based on two questions (did he/she grunt or make a face like he/she was straining). Lower value represents a better outcome and "I don't know" is considered as a missing response. The subject's average straining score for each caregiver-observed BM was derived based on the average of non-missing responses of the two straining questions. The participant's straining score in the 4-week Study Intervention Period was the average of the non-missing average straining scores from all caregiver-observed SBMs during the 4-week Study Intervention Period. If a subject had no caregiver-observed SBMs at baseline, then the baseline straining score reported by the caregiver was missing and, therefore, that subject was not included in the change from baseline straining analysis. - **Number of Participants With Adverse Events (AEs)** _(time frame: Up to Week 5)_ — An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. ## Locations (38) - Velocity Clinical Research - Phoenix /ID# 263871, Phoenix, Arizona, United States - HealthStar Research of Hot Springs PLLC /ID# 251553, Hot Springs, Arkansas, United States - Advanced Research Center /ID# 248763, Anaheim, California, United States - Kindred Medical Institute - Corona /ID# 251535, Corona, California, United States - Velocity Clinical Research Washington DC /ID# 263872, Washington D.C., District of Columbia, United States - Prohealth Research Center /ID# 248696, Doral, Florida, United States - South Miami Medical & Research Group Inc. /ID# 248765, Miami, Florida, United States - Valencia Medical & Research Center /ID# 251533, Miami, Florida, United States - Velocity Clinical Research Macon /ID# 263959, Macon, Georgia, United States - Velocity Clinical Research - Lafayette /ID# 263873, Lafayette, Louisiana, United States - Frederick County Pediatrics /ID# 251555, New Market, Maryland, United States - Michigan Center of Medical Research /ID# 253536, Farmington Hills, Michigan, United States - Velocity Clinical Research- Hastings Nebraska /ID# 260932, Hastings, Nebraska, United States - Coastal Pediatric Research - West Ashley B /ID# 248693, Charleston, South Carolina, United States - Coastal Pediatric Research - Summerville /ID# 253534, Summerville, South Carolina, United States - Houston Clinical Research Associates /ID# 261571, Houston, Texas, United States - Prime Clinical Research - Mansfield - East Broad Street /ID# 262947, Mansfield, Texas, United States - ClinPoint Trials /ID# 251534, Waxahachie, Texas, United States - UMHAT Sveti Georgi /ID# 250808, Plovdiv, Bulgaria - UMHAT Kanev /ID# 248931, Rousse, Bulgaria - Acibadem City Clinic Tokuda University Hospital EAD /ID# 251232, Sofia, Bulgaria - Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251229, Sofia, Bulgaria - Nova Clinic /ID# 249023, Varna, Bulgaria - Klinicki bolnicki centar Sestre milosrdnice /ID# 252798, Zagreb, City of Zagreb, Croatia - Klinicki bolnicki centar Zagreb /ID# 252796, Zagreb, City of Zagreb, Croatia - Klinika za dječje bolesti Zagreb /ID# 252792, Zagreb, City of Zagreb, Croatia - Klinicki bolnicki centar Osijek /ID# 252795, Osijek, County of Osijek-Baranja, Croatia - Universitaetsklinikum Muenster /ID# 251965, Münster, North Rhine-Westphalia, Germany - Kinderarztpraxis Dr. Froehlich /ID# 252050, Forchheim, Germany - HELIOS Klinikum Wuppertal /ID# 249022, Wuppertal, Germany - Debreceni Egyetem-Klinikai Kozpont /ID# 250793, Debrecen, Hajdú-Bihar, Hungary - Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 252485, Belgrade, Beograd, Serbia - University Children's Hospital 'Tirsova' /ID# 252483, Belgrade, Beograd, Serbia - Institute for Child and Youth Health Care of Vojvodina /ID# 252482, Novi Sad, Serbia - Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 252298, London, Greater London, United Kingdom - Great Ormond Street Children's Hospital /ID# 253333, London, Greater London, United Kingdom - Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252299, Norwich, Norfolk, United Kingdom - Russells Hall Hospital /ID# 252660, Dudley, United Kingdom ## Recent Field Changes (last 30 days) - `design.phases` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.velocity clinical research - phoenix /id# 263871|phoenix|arizona|united states` — added _(2026-05-12)_ - `locations.healthstar research of hot springs pllc /id# 251553|hot springs|arkansas|united states` — added _(2026-05-12)_ - `locations.advanced research center /id# 248763|anaheim|california|united states` — added _(2026-05-12)_ - `locations.kindred medical institute - corona /id# 251535|corona|california|united states` — added _(2026-05-12)_ - `locations.velocity clinical research washington dc /id# 263872|washington d.c.|district of columbia|united states` — added _(2026-05-12)_ - `locations.prohealth research center /id# 248696|doral|florida|united states` — added _(2026-05-12)_ - `locations.south miami medical & research group inc. /id# 248765|miami|florida|united states` — added _(2026-05-12)_ - `locations.valencia medical & research center /id# 251533|miami|florida|united states` — added _(2026-05-12)_ - `locations.velocity clinical research macon /id# 263959|macon|georgia|united states` — added _(2026-05-12)_ - `locations.velocity clinical research - lafayette /id# 263873|lafayette|louisiana|united states` — added _(2026-05-12)_ - `locations.frederick county pediatrics /id# 251555|new market|maryland|united states` — added _(2026-05-12)_ - `locations.michigan center of medical research /id# 253536|farmington hills|michigan|united states` — added _(2026-05-12)_ - `locations.velocity clinical research- hastings nebraska /id# 260932|hastings|nebraska|united states` — added _(2026-05-12)_ - `locations.coastal pediatric research - west ashley b /id# 248693|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.coastal pediatric research - summerville /id# 253534|summerville|south carolina|united states` — added _(2026-05-12)_ - `locations.houston clinical research associates /id# 261571|houston|texas|united states` — added _(2026-05-12)_ - `locations.prime clinical research - mansfield - east broad street /id# 262947|mansfield|texas|united states` — added _(2026-05-12)_ - `locations.clinpoint trials /id# 251534|waxahachie|texas|united states` — added _(2026-05-12)_ - `locations.umhat sveti georgi /id# 250808|plovdiv||bulgaria` — added _(2026-05-12)_ - `locations.umhat kanev /id# 248931|rousse||bulgaria` — added _(2026-05-12)_ - `locations.acibadem city clinic tokuda university hospital ead /id# 251232|sofia||bulgaria` — added _(2026-05-12)_ - `locations.specialized hospital for active treatment of children diseases prof. ivan mitev /id# 251229|sofia||bulgaria` — added _(2026-05-12)_ - `locations.nova clinic /id# 249023|varna||bulgaria` — added _(2026-05-12)_ - `locations.klinicki bolnicki centar sestre milosrdnice /id# 252798|zagreb|city of zagreb|croatia` — added _(2026-05-12)_ - `locations.klinicki bolnicki centar zagreb /id# 252796|zagreb|city of zagreb|croatia` — added _(2026-05-12)_ - `locations.klinika za dječje bolesti zagreb /id# 252792|zagreb|city of zagreb|croatia` — added _(2026-05-12)_ - `locations.klinicki bolnicki centar osijek /id# 252795|osijek|county of osijek-baranja|croatia` — added _(2026-05-12)_ - `locations.universitaetsklinikum muenster /id# 251965|münster|north rhine-westphalia|germany` — added _(2026-05-12)_ - `locations.kinderarztpraxis dr. froehlich /id# 252050|forchheim||germany` — added _(2026-05-12)_ - `locations.helios klinikum wuppertal /id# 249022|wuppertal||germany` — added _(2026-05-12)_ - `locations.debreceni egyetem-klinikai kozpont /id# 250793|debrecen|hajdú-bihar|hungary` — added _(2026-05-12)_ - `locations.institut za zdravstvenu zastitu majke i deteta srbije dr vukan cupic /id# 252485|belgrade|beograd|serbia` — added _(2026-05-12)_ - `locations.university children's hospital 'tirsova' /id# 252483|belgrade|beograd|serbia` — added _(2026-05-12)_ - `locations.institute for child and youth health care of vojvodina /id# 252482|novi sad||serbia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05760313.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05760313* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*