Trial · NCT05760313
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
NCT05760313, Phase 2, Completed, AbbVie; results first posted 2026-01-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT05760313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05760313
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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 number
- NCT05760313
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Functional Constipation
- Interventions
- Linaclotide, Placebo
- First posted
- 2023-03-08
- Last updated
- 2026-01-06
- Results first posted
- 2026-01-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period | 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. |
| Primary | Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period | 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. |
| Primary | Change From Baseline in Straining During the Study Intervention Period | 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. |
| Primary | Number of Participants With Adverse Events (AEs) | 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. |
Source ClinicalTrials.gov
Outcomes4
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 Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period | Baseline to Week 4 | The ITT population was used for all efficacy and baseline analyses. | SBMs/Week | MEAN |
| PRIMARY | Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period | Baseline to Week 4 | The ITT population was used for all efficacy and baseline analyses. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Straining During the Study Intervention Period | Baseline to Week 4 | The ITT population was used for all efficacy and baseline analyses. | score on a scale | MEAN |
| PRIMARY | Number of Participants With Adverse Events (AEs) | Up to Week 5 | The SA analysis population was used for safety analyses. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
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 Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period | Open-Label Linaclotide 9 µg (Part 1) | Observed by the LAR/Parent/Guardian/Caregiver | 3.181 | Standard Deviation 0.9563 | SBMs/Week |
| Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period | Double-Blind Placebo (Part 2) | Observed by the LAR/Parent/Guardian/Caregiver | 2.503 | Standard Deviation 1.3791 | SBMs/Week |
| Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period | Double-Blind Linaclotide 9 µg (Part 2) | Observed by the LAR/Parent/Guardian/Caregiver | 0.246 | Standard Deviation 0.7035 | SBMs/Week |
| Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period | Open-Label Linaclotide 9 µg (Part 1) | All Reported by the LAR/Parent/Guardian/Caregiver | 3.371 | Standard Deviation 0.9858 | SBMs/Week |
| Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period | Double-Blind Placebo (Part 2) | All Reported by the LAR/Parent/Guardian/Caregiver | 2.577 | Standard Deviation 1.4293 | SBMs/Week |
| Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period | Double-Blind Linaclotide 9 µg (Part 2) | All Reported by the LAR/Parent/Guardian/Caregiver | 0.895 | Standard Deviation 1.1475 | SBMs/Week |
| Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period | Open-Label Linaclotide 9 µg (Part 1) | 0.845 | Standard Deviation 2.1137 | units on a scale | |
| Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period | Double-Blind Placebo (Part 2) | 1.062 | Standard Deviation 0.8043 | units on a scale | |
| Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period | Double-Blind Linaclotide 9 µg (Part 2) | 1.201 | Standard Deviation 1.0192 | units on a scale | |
| Change From Baseline in Straining During the Study Intervention Period | Open-Label Linaclotide 9 µg (Part 1) | -1.087 | Standard Deviation 0.6511 | score on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open-Label Linaclotide 9 µg (Part 1) | 7 | |
| Overall Study | STARTED | Double-Blind Placebo (Part 2) | 6 | |
| Overall Study | STARTED | Double-Blind Linaclotide 9 µg (Part 2) | 6 | |
| Overall Study | COMPLETED | Open-Label Linaclotide 9 µg (Part 1) | 6 | |
| Overall Study | COMPLETED | Double-Blind Placebo (Part 2) | 6 | |
| Overall Study | COMPLETED | Double-Blind Linaclotide 9 µg (Part 2) | 5 | |
| Overall Study | NOT COMPLETED | Open-Label Linaclotide 9 µg (Part 1) | 1 | |
| Overall Study | NOT COMPLETED | Double-Blind Placebo (Part 2) | 0 | |
| Overall Study | NOT COMPLETED | Double-Blind Linaclotide 9 µg (Part 2) | 1 |
Source ClinicalTrials.gov
Adverse events33
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 | DIARRHOEA | Gastrointestinal disorders | Double-Blind Placebo (Part 2) | 0 | 6 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | Double-Blind Linaclotide 9 µg (Part 2) | 0 | 6 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | Open-Label Linaclotide 9 µg (Part 1) | 2 | 7 | 2 |
| other | CONJUNCTIVITIS VIRAL | Infections and infestations | Double-Blind Placebo (Part 2) | 0 | 6 | 0 |
| other | CONJUNCTIVITIS VIRAL | Infections and infestations | Double-Blind Linaclotide 9 µg (Part 2) | 1 | 6 | 1 |
| other | CONJUNCTIVITIS VIRAL | Infections and infestations | Open-Label Linaclotide 9 µg (Part 1) | 0 | 7 | 0 |
| other | INFLUENZA | Infections and infestations | Double-Blind Placebo (Part 2) | 0 | 6 | 0 |
| other | INFLUENZA | Infections and infestations | Double-Blind Linaclotide 9 µg (Part 2) | 1 | 6 | 1 |
| other | INFLUENZA | Infections and infestations | Open-Label Linaclotide 9 µg (Part 1) | 1 | 7 | 1 |
| other | OTITIS MEDIA ACUTE | Infections and infestations | Double-Blind Placebo (Part 2) | 0 | 6 | 0 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-Blind Placebo (Part 2) | 0 | 6 |
| Total, all-cause mortality | Double-Blind Linaclotide 9 µg (Part 2) | 0 | 6 |
| Total, all-cause mortality | Open-Label Linaclotide 9 µg (Part 1) | 0 | 7 |
| Total, other adverse events | Double-Blind Placebo (Part 2) | 1 | 6 |
| Total, other adverse events | Double-Blind Linaclotide 9 µg (Part 2) | 3 | 6 |
| Total, other adverse events | Open-Label Linaclotide 9 µg (Part 1) | 3 | 7 |
| Total, serious adverse events | Double-Blind Placebo (Part 2) | 0 | 6 |
| Total, serious adverse events | Double-Blind Linaclotide 9 µg (Part 2) | 0 | 6 |
| Total, serious adverse events | Open-Label Linaclotide 9 µg (Part 1) | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05760313
GET https://conductscience.org/api/trials/v1/NCT05760313/events?page=2