Trial · NCT04110145
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
NCT04110145, Phase 2, Completed, Allergan; results first posted 2022-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation. Trials, record NCT04110145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04110145
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
- NCT number
- NCT04110145
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Functional Constipation
- Interventions
- Linaclotide, Placebo
- First posted
- 2019-10-01
- Last updated
- 2022-04-26
- Other registries' IDs
- eudract:2019-002126-75
- Results first posted
- 2022-04-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period of Each Cohort | Baseline (14 days prior to randomization) to Day 29 | 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. |
| Primary | Change From Baseline in 4-week Stool Consistency Reported by the Caregiver During the Study Intervention Period of Each Cohort | Baseline (14 days prior to randomization) to Day 29 | 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. |
| Primary | Change From Baseline in 4-week Straining Reported by the Caregiver During the Study Intervention Period of Each Cohort | Baseline (14 days prior to randomization) to Day 29 | 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. |
| Primary | 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 | 29 Days | 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. |
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | First dose of study drug intervention to within 1 week of last dose (Up to 45 days) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period of Each Cohort | Baseline (14 days prior to randomization) to Day 29 | mITT Population included all Randomized Population who received at least 1 dose of double-blind study intervention and who had at least 1 postbaseline entry on BM characteristic assessments that determine occurrences of SBMs. | SBMs per week | MEAN |
| PRIMARY | Change From Baseline in 4-week Stool Consistency Reported by the Caregiver During the Study Intervention Period of Each Cohort | Baseline (14 days prior to randomization) to Day 29 | mITT Population included all Randomized Population who received at least 1 dose of double-blind study intervention and who had at least 1 postbaseline entry on BM characteristic assessments that determine occurrences of SBMs. Overall number analyzed are the number of participants with data available for analyses. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in 4-week Straining Reported by the Caregiver During the Study Intervention Period of Each Cohort | Baseline (14 days prior to randomization) to Day 29 | mITT Population included all Randomized Population who received at least 1 dose of double-blind study intervention and who had at least 1 postbaseline entry on BM characteristic assessments that determine occurrences of SBMs. Overall number analyzed are the number of participants with data available for analyses. | straining score | MEAN |
| PRIMARY | 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 | 29 Days | mITT Population included all Randomized Population who received at least 1 dose of double-blind study intervention and who had at least 1 postbaseline entry on BM characteristic assessments that determine occurrences of SBMs. Number analyzed is the number of participants with data available for analyses. | percentage of days | MEAN |
| PRIMARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | First dose of study drug intervention to within 1 week of last dose (Up to 45 days) | Safety Population included all participants in the Randomized Population who received at least 1 dose of double-blind study intervention. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period of Each Cohort | Cohort 1 (Linaclotide 18 μg) | Baseline | 1.379 | Standard Deviation 1.095 | 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 | Cohort 2 (Linaclotide 36 μg) | Baseline | 0.621 | Standard Deviation 0.365 | 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 | Cohort 3 (Linaclotide 72 μg) | Baseline | 0.724 | Standard Deviation 0.953 | 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 | Final Cohort (Linaclotide 72 μg) | Baseline | 1.034 | Standard Deviation 0.809 | 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 | Placebo Pooled | Baseline | 1.267 | Standard Deviation 1.062 | 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 | Cohort 1 (Linaclotide 18 μg) | Change from Baseline to Day 29 | 3.100 | Standard Deviation 5.251 | 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 | Cohort 2 (Linaclotide 36 μg) | Change from Baseline to Day 29 | 0.032 | Standard Deviation 0.508 | 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 | Cohort 3 (Linaclotide 72 μg) | Change from Baseline to Day 29 | 3.603 | Standard Deviation 2.867 | 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 | Final Cohort (Linaclotide 72 μg) | Change from Baseline to Day 29 | 1.574 | Standard Deviation 1.933 | 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 | Placebo Pooled | Change from Baseline to Day 29 | 0.482 | Standard Deviation 0.773 | SBMs per week |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment Period (4 Weeks) | STARTED | Cohort 1 (Linaclotide 18 μg) | 7 | |
| Double-Blind Treatment Period (4 Weeks) | STARTED | Cohort 2 (Linaclotide 36 μg) | 7 | |
| Double-Blind Treatment Period (4 Weeks) | STARTED | Cohort 3 (Linaclotide 72 μg) | 6 | |
| Double-Blind Treatment Period (4 Weeks) | STARTED | Final Cohort (Linaclotide 72 μg) | 7 | |
| Double-Blind Treatment Period (4 Weeks) | STARTED | Placebo Pooled | 8 | |
| Double-Blind Treatment Period (4 Weeks) | COMPLETED | Cohort 1 (Linaclotide 18 μg) | 7 | |
| Double-Blind Treatment Period (4 Weeks) | COMPLETED | Cohort 2 (Linaclotide 36 μg) | 7 | |
| Double-Blind Treatment Period (4 Weeks) | COMPLETED | Cohort 3 (Linaclotide 72 μg) | 6 | |
| Double-Blind Treatment Period (4 Weeks) | COMPLETED | Final Cohort (Linaclotide 72 μg) | 6 | |
| Double-Blind Treatment Period (4 Weeks) | COMPLETED | Placebo Pooled | 8 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Otitis media | Infections and infestations | Cohort 1 (Linaclotide 18 μg) | 1 | 7 | |
| other | Otitis media | Infections and infestations | Cohort 2 (Linaclotide 36 μg) | 0 | 7 | |
| other | Otitis media | Infections and infestations | Cohort 3 (Linaclotide 72 μg) | 0 | 6 | |
| other | Otitis media | Infections and infestations | Final Cohort (Linaclotide 72 μg) | 0 | 7 | |
| other | Otitis media | Infections and infestations | Placebo Pooled | 0 | 8 | |
| other | Blood creatinine increased | Investigations | Cohort 1 (Linaclotide 18 μg) | 1 | 7 | |
| other | Blood creatinine increased | Investigations | Cohort 2 (Linaclotide 36 μg) | 0 | 7 | |
| other | Blood creatinine increased | Investigations | Cohort 3 (Linaclotide 72 μg) | 0 | 6 | |
| other | Blood creatinine increased | Investigations | Final Cohort (Linaclotide 72 μg) | 0 | 7 | |
| other | Blood creatinine increased | Investigations | Placebo Pooled | 0 | 8 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (Linaclotide 18 μg) | 0 | 7 |
| Total, all-cause mortality | Cohort 2 (Linaclotide 36 μg) | 0 | 7 |
| Total, all-cause mortality | Cohort 3 (Linaclotide 72 μg) | 0 | 6 |
| Total, all-cause mortality | Final Cohort (Linaclotide 72 μg) | 0 | 7 |
| Total, all-cause mortality | Placebo Pooled | 0 | 8 |
| Total, other adverse events | Cohort 1 (Linaclotide 18 μg) | 2 | 7 |
| Total, other adverse events | Cohort 2 (Linaclotide 36 μg) | 0 | 7 |
| Total, other adverse events | Cohort 3 (Linaclotide 72 μg) | 0 | 6 |
| Total, other adverse events | Final Cohort (Linaclotide 72 μg) | 2 | 7 |
| Total, other adverse events | Placebo Pooled | 1 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38962910 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04110145
GET https://conductscience.org/api/trials/v1/NCT04110145/results?page=2