CompletedNCT04110145Updated Apr 26, 2022Results posted

Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation

A Phase 2 interventional study of Linaclotide and Placebo in Functional Constipation, sponsored by Allergan. Completed at 18 sites in United States. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2022-04-26.

Sponsored by Allergan (part of AbbVie) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 35
Allocation: Randomized
Ages: 2 Years to 5 Years
Sex: All

Study summary

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.

Conditions studied

Functional Constipation

Keywords

Functional constipation in children
LINZESS

In context

Lead sponsor

Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.

First submitted before Allergan became part of AbbVie.

Browse Allergan studies →All AbbVie studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 5 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participant weighs ≥10 kilograms (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 \< 4 years old), 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) per week.

In addition, at least once per week, participant must meet 1 or more of the following:

History of retentive posturing or excessive volitional stool retention
History of painful or hard bowel movements (BMs)
Presence of a large fecal mass in the rectum
History of large diameter stools that may obstruct the toilet
At least one episode of fecal incontinence per week after the acquisition of toileting skills
- Participant is willing to discontinue any laxatives used before the Preintervention Visit in favor of the protocol-permitted rescue medicine
- Parent/guardian/LAR and caregiver must provide written informed consent before the initiation of any study-specific procedures
- Caregiver who will be completing the eDiary is able to read and/or understand the assessments in the eDiary device and must undergo training

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:
1. Improvement with defecation
2. Onset associated with a change in frequency of stool
3. 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:
1. Surgery to remove a segment of the GI tract at any time before Screening (Visit 1)
2. Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit
3. An appendectomy or cholecystectomy during the 60 days before Screening (Visit 1)
4. 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:
1. Celiac disease, or positive serological test for celiac disease or the condition is suspected but has not been ruled out by endoscopic biopsy
2. Cystic fibrosis
3. 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)
4. Down's syndrome or any other chromosomal disorder
5. 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.
6. Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus)
7. Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies)
8. Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma)
9. Lead toxicity, hypercalcemia
10. 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.)
11. Inflammatory bowel disease
12. Childhood functional abdominal pain syndrome
13. Childhood functional abdominal pain
14. Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study
15. Lactose intolerance that is associated with symptoms which could confound the assessments in this study
16. 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 before the Randomization Visit. A complete remission is defined as the disappearance of all signs of cancer in response to treatment.)

Participant received a study intervention during the 30 days before Screening (Visit 1) or is planning to receive study intervention (other than that administered during this study)
Participant's parent/guardian/LAR or caregiver has been directly or indirectly involved in the conduct and administration of this study as an investigator, study coordinator, or other study staff member. In addition, any participant, parent/guardian/LAR or caregiver who has a first-degree family member, significant other, or relative residing with him/her directly or indirectly who is involved in this study
For participants aged ≥ 4 years old: Participant has a history of non-retentive fecal incontinence

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 35 participants (actual)

Study arms

Experimental
Cohort 1 (Linaclotide 18 μg)
Linaclotide 18 microgram (μg), capsules, mixed with water and administered orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
Drug: Linaclotide
Experimental
Cohort 2 (Linaclotide 36 μg)
Linaclotide 36 μg, capsules, mixed with water and administered orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
Drug: Linaclotide
Experimental
Cohort 3 (Linaclotide 72 μg)
Linaclotide 72 μg, capsules, mixed with water and administered orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
Drug: Linaclotide
Experimental
Final Cohort (Linaclotide 72 μg)
Linaclotide at the highest dose tested/determined to be safe (72 μg), capsules, mixed with water and administered orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period.
Drug: Linaclotide
Placebo comparator
Placebo Pooled
Matching placebo, orally, once daily in fasted state (30 minutes before any meal) for the 4-week Study Intervention Period pooled from Cohorts 1, 2, 3, and Final Cohort.
Drug: Placebo

Interventions

DrugLinaclotide
Linaclotide, capsules, mixed with water and administered orally, once daily in fasted state.
DrugPlacebo
Matching placebo, capsules, mixed with water and administered orally, once daily in fasted state

What researchers measure

Primary outcomes

Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period of Each Cohort
A SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. Each day the caregiver recorded the number of SBMs in the last 24 hours in an electronic diary (eDiary). The SBM frequency rate (SBMs/week) during the analysis period for each participant was calculated as \[(total number of SBMs in the analysis period/number of days in the analysis period)\*7\]. Baseline value was based on values collected 14 days before randomization up to randomization. Change from Baseline was calculated as the SBM frequency rate during the 4-week treatment period - SBM frequency rate at Baseline. A positive change from Baseline indicates improvement.
Time frame: Baseline (14 days prior to randomization) to Day 29
Change From Baseline in 4-week Stool Consistency Reported by the Caregiver During the Study Intervention Period of Each Cohort
The caregiver rated and recorded in an eDiary the consistency of the stool for each bowel movement using the Bristol Stool Form 7-point scale where: 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; 7=Watery, no solid pieces. Entirely liquid. Baseline value was based on values collected 14 days before randomization up to randomization. A participant's stool consistency score for the treatment period was the average of the nonmissing consistency scores from the BMs recorded by the caregiver during the 4-week treatment period.
Time frame: Baseline (14 days prior to randomization) to Day 29
Change From Baseline in 4-week Straining Reported by the Caregiver During the Study Intervention Period of Each Cohort
The caregiver rated and recorded in an eDiary the amount of straining they observed when the child passed the BM (1=Not at all; 2=Yes a little; 3=Yes a lot; I don't know). Baseline value was based on values collected 14 days before randomization up to randomization. A participant's straining score for the treatment period was the average of the nonmissing straining scores from the BMs recorded by the caregiver during the 4-week treatment period. A negative change from Baseline indicates improvement.
Time frame: Baseline (14 days prior to randomization) to Day 29
Percentage 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
Each day the caregiver recorded in an eDiary if the child had a bowel movement accident (Yes; No; I don't know). The percentage of days with fecal incontinence for the treatment period was the average of the nonmissing incidences of fecal incontinence recorded by the caregiver during the 4-week treatment period.
Time frame: 29 Days
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that: results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and/or causes a congenital anomaly/birth defect. A TEAE is an AE that begins or worsens after receiving study drug. Safety Population included all participants in the Randomized Population who received at least 1 dose of double-blind study intervention.
Time frame: First dose of study drug intervention to within 1 week of last dose (Up to 45 days)

Results

Posted Apr 26, 2022

Participant flow

Double-Blind Treatment Period (4 Weeks)

Participant flow — Double-Blind Treatment Period (4 Weeks)
Milestone	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled
Started	7	7	6	7	8
Completed	7	7	6	6	8
Not completed	0	0	0	1	0
Withdrew: Site terminated by the sponsor	0	0	0	1	0

Post-Treatment Period (1 Week)

Participant flow — Post-Treatment Period (1 Week)
Milestone	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled
Started	7	7	5	6	8
Completed	7	7	5	6	8
Not completed	0	0	0	0	0

Outcome measures

PrimaryChange From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period of Each Cohort

A SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. Each day the caregiver recorded the number of SBMs in the last 24 hours in an electronic diary (eDiary). The SBM frequency rate (SBMs/week) during the analysis period for each participant was calculated as \[(total number of SBMs in the analysis period/number of days in the analysis period)\*7\]. Baseline value was based on values collected 14 days before randomization up to randomization. Change from Baseline was calculated as the SBM frequency rate during the 4-week treatment period - SBM frequency rate at Baseline. A positive change from Baseline indicates improvement.

Time frame:: Baseline (14 days prior to randomization) to Day 29
Reported as:: Mean · SBMs per week

Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period of Each Cohort
SBMs per week	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled
Baseline	1.379 ± 1.095	0.621 ± 0.365	0.724 ± 0.953	1.034 ± 0.809	1.267 ± 1.062
Change from Baseline to Day 29	3.100 ± 5.251	0.032 ± 0.508	3.603 ± 2.867	1.574 ± 1.933	0.482 ± 0.773

PrimaryChange From Baseline in 4-week Stool Consistency Reported by the Caregiver During the Study Intervention Period of Each Cohort

The caregiver rated and recorded in an eDiary the consistency of the stool for each bowel movement using the Bristol Stool Form 7-point scale where: 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; 7=Watery, no solid pieces. Entirely liquid. Baseline value was based on values collected 14 days before randomization up to randomization. A participant's stool consistency score for the treatment period was the average of the nonmissing consistency scores from the BMs recorded by the caregiver during the 4-week treatment period.

Time frame:: Baseline (14 days prior to randomization) to Day 29
Reported as:: Mean · score on a scale

Change From Baseline in 4-week Stool Consistency Reported by the Caregiver During the Study Intervention Period of Each Cohort
score on a scale	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled
Baseline	1.633 ± 0.461	1.700 ± 0.447	2.733 ± 1.079	2.021 ± 0.793	2.024 ± 0.641
Change from Baseline to Day 29	0.917 ± 1.360	1.600 ± 1.294	1.687 ± 2.779	1.716 ± 1.689	0.596 ± 0.937

PrimaryChange From Baseline in 4-week Straining Reported by the Caregiver During the Study Intervention Period of Each Cohort

The caregiver rated and recorded in an eDiary the amount of straining they observed when the child passed the BM (1=Not at all; 2=Yes a little; 3=Yes a lot; I don't know). Baseline value was based on values collected 14 days before randomization up to randomization. A participant's straining score for the treatment period was the average of the nonmissing straining scores from the BMs recorded by the caregiver during the 4-week treatment period. A negative change from Baseline indicates improvement.

Time frame:: Baseline (14 days prior to randomization) to Day 29
Reported as:: Mean · straining score

Change From Baseline in 4-week Straining Reported by the Caregiver During the Study Intervention Period of Each Cohort
straining score	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled
Baseline	2.310 ± 0.410	2.600 ± 0.379	2.600 ± 0.361	2.571 ± 0.426	2.548 ± 0.658
Change from Baseline to Day 29	-0.370 ± 0.631	-0.320 ± 0.325	-0.769 ± 0.884	-0.996 ± 0.759	-0.334 ± 0.360

PrimaryPercentage 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

Each day the caregiver recorded in an eDiary if the child had a bowel movement accident (Yes; No; I don't know). The percentage of days with fecal incontinence for the treatment period was the average of the nonmissing incidences of fecal incontinence recorded by the caregiver during the 4-week treatment period.

Time frame:: 29 Days
Reported as:: Mean · percentage of days

Percentage 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
percentage of days	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled
Percentage 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	0.007 ± 0.016	0.065 ± 0.107	0.091 ± 0.063	0.009 ± 0.019	0.000 ± 0.000

PrimaryPercentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that: results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and/or causes a congenital anomaly/birth defect. A TEAE is an AE that begins or worsens after receiving study drug. Safety Population included all participants in the Randomized Population who received at least 1 dose of double-blind study intervention.

Time frame:: First dose of study drug intervention to within 1 week of last dose (Up to 45 days)
Reported as:: Number · percentage of participants

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
percentage of participants	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled
TEAEs	28.6	0.0	0.0	28.6	12.5
TESAE	0.0	0.0	0.0	0.0	0.0

Adverse events

Collected over First dose of study drug intervention to within 1 week of last dose (Up to 45 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1 (Linaclotide 18 μg)	0/7 (0%)	0/7 (0%)	2/7 (28.6%)
Cohort 2 (Linaclotide 36 μg)	0/7 (0%)	0/7 (0%)	0/7 (0%)
Cohort 3 (Linaclotide 72 μg)	0/6 (0%)	0/6 (0%)	0/6 (0%)
Final Cohort (Linaclotide 72 μg)	0/7 (0%)	0/7 (0%)	2/7 (28.6%)
Placebo Pooled	0/8 (0%)	0/8 (0%)	1/8 (12.5%)

Most frequent other events

Most frequent other events
Event	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled
Otitis mediaInfections and infestations	1/7	0/7	0/6	0/7	0/8
Blood creatinine increasedInvestigations	1/7	0/7	0/6	0/7	0/8
CoughRespiratory, thoracic and mediastinal disorders	1/7	0/7	0/6	0/7	0/8
Abdominal pain upperGastrointestinal disorders	0/7	0/7	0/6	1/7	0/8
DiarrhoeaGastrointestinal disorders	0/7	0/7	0/6	1/7	0/8
Ear infectionInfections and infestations	0/7	0/7	0/6	1/7	0/8
Developmental delayGeneral disorders	0/7	0/7	0/6	0/7	1/8

Baseline characteristics

Modified Intent-to-Treat Population (mITT) included all Randomized Population who received at least 1 dose of double-blind study intervention and who had at least 1 postbaseline entry on bowel movement (BM) characteristic assessments that determine occurrences of spontaneous bowel movements (SBMs).

Age, Continuous
Age, Continuous(years)	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled	Total
Mean	3.6 (2 to 5)	3.3 (2 to 5)	4.0 (3 to 5)	3.6 (2 to 5)	3.5 (3 to 4)	3.6 (2 to 5)

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled	Total
Female	4	3	5	0	4	16
Male	3	4	1	7	4	19

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled	Total
Hispanic or Latino	1	2	4	4	3	14
Not Hispanic or Latino	6	5	2	3	5	21
Unknown or Not Reported	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort 1 (Linaclotide 18 μg)	Cohort 2 (Linaclotide 36 μg)	Cohort 3 (Linaclotide 72 μg)	Final Cohort (Linaclotide 72 μg)	Placebo Pooled	Total
American Indian or Alaska Native	0	0	0	0	0	0
Asian	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	5	4	2	2	3	16
White	2	3	4	5	5	19
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0

Study locations

18 sites

Central Research Associates, Inc
Birmingham, Alabama 35205, United States
HealthStar Research
Hot Springs, Arkansas 71913, United States
Preferred Clinical Research Partners
Little Rock, Arkansas 72211, United States
Advanced Research Center
Anaheim, California 92805, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California 92879, United States
Center for Clinical Trials, LLC
Paramount, California 90723, United States
Prohealth Research Center
Doral, Florida 33166, United States
South Miami Medical & Research Group, Inc.
Miami, Florida 33155, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia 30513, United States
SleepCare Research Institute, Inc.
Stockbridge, Georgia 30281, United States
Virgo Carter Pediatrics
Silver Spring, Maryland 20910, United States
Minnesota Gastroenterology PA
Minneapolis, Minnesota 55413, United States
David M. Headley, MD, P.A.
Port Gibson, Mississippi 39150, United States
Foundation Pediatrics Med Clinical Research Partners, LLC
East Orange, New Jersey 07108, United States
Advantage Clinical Trials
The Bronx, New York 10468, United States
Coastal Pediatric Research
Charleston, South Carolina 29414, United States
Coastal Pediatric Research
Mt. Pleasant, South Carolina 29464, United States
Clinical Research Partners, LLC
Richmond, Virginia 23220, United States

References and documents

Publications

Di Lorenzo C, Robert J, Rodriguez-Araujo G, Shakhnovich V, Xie W, Nurko S, Saps M. Safety and efficacy of linaclotide in children aged 2-5 years with functional constipation: Phase 2, randomized study. J Pediatr Gastroenterol Nutr. 2024 Sep;79(3):510-518. doi: 10.1002/jpn3.12306. Epub 2024 Jul 4. PubMed 38962910 ↗

Study documents

Study protocol · May 4, 2020
Statistical analysis plan · May 11, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.

Supporting information: Study protocol, Clinical study report

Time frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.

Access criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.

Data sharing details ↗ · www.allerganclinicaltrials.com

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2019 to primary completion in Apr 2021, 18 months.

Results were first posted in Apr 2022, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 27, 2019
First posted: Oct 1, 2019
StartActual: Oct 14, 2019
Primary completionActual: Apr 20, 2021
CompletionActual: Apr 20, 2021
Results first posted: Apr 26, 2022
Last update: Apr 26, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04110145
Lead sponsor: Allergan
Collaborators: Ironwood Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Oct 1, 2019
Start date: Oct 14, 2019
Primary completion: Apr 20, 2021
Completion: Apr 20, 2021
Results posted: Apr 26, 2022
Last update: Apr 26, 2022

Study contacts

Anna Muslin

study director · Allergan

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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