Trial · NCT02559817

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation

NCT02559817, Phase 2, Terminated, Forest Laboratories; results first posted 2020-12-28

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation. Trials, record NCT02559817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02559817

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation
NCT number: NCT02559817
Status: Terminated
Phases: Phase 2
Enrollment: 101 participants, actual
Lead sponsor: Forest Laboratories
Conditions: Irritable Bowel Syndrome With Constipation
Interventions: Linaclotide Dose A, Linaclotide Dose B, Linaclotide Dose C, Linaclotide Approved Adult Dose, Matching Placebo
First posted: 2015-09-24
Last updated: 2020-12-28
Results first posted: 2020-12-28
Limitations and caveats: Due to slow participant enrollment, further screening was terminated. This decision was not due to any safety concern.

Source ClinicalTrials.gov

Registered outcomes6

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 Treatment Period	Baseline (14 days prior to randomization and up to randomization) to week 4	SBM was defined as a 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. SBM rate was defined as SBMs/week during the 4-week Treatment period. Participants recorded the occurrence of BMs and use of rescue medication, morning and evening, daily in an eDiary since pretreatment period. The SBM frequency rate (SBMs/week) during the analysis period for each participant were 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.
Secondary	Change From Baseline in 4-week Abdominal Pain Daytime Symptoms Based on Evening Assessment of Abdominal Pain Symptoms	Baseline (14 days prior to randomization) to week 4	The abdominal pain score was measured using 5-point scale. Participants answered the questions, How much did your tummy hurt as: 0=none, 1=a tiny bit, 2=a little, 3=some, and 4=a lot. The 4-week daytime abdominal pain was calculated as the average of nonmissing scores in evening eDiary during the Treatment Period with higher value indicating greater symptom severity. Baseline value was the average of non-missing values collected 14 days before randomization. Change from Baseline was calculated as the daytime abdominal pain score during the 4-week treatment period (i.e. average of non-missing daytime scores during 4-week treatment period) - daytime abdominal pain score at baseline. A negative change from Baseline indicates improvement.
Secondary	Change From Baseline in 4-week Stool Consistency	Baseline (14 days prior to randomization and up to randomization) to week 4	Participants used 7-point pediatric Bristol Stool Form (p-BSFS) scale to rate stool consistency for each BM in morning and evening eDiary where 1=small hard lumps or balls like pebbles,2=fat sausage shape but lumpy and hard,3=a sausage but with cracks on it,4=sausage or snake, smooth and soft,5=chicken nuggets, soft smooth blobs,6=oatmeal, fluffy mushy pieces,7=milkshake, watery. Scores in 4-week treatment period were calculated as mean of participants non-missing, SBM associated p-BSFS scores during 4-week treatment period. Baseline value was based on values collected 14 days before randomization up to randomization.
Secondary	Change From Baseline in 4-week Severity of Straining	Baseline (14 days prior to randomization and up to randomization) to week 4	Severity of straining was scored on 5-point scale for question-When you pooped, how hard did you push? The score ranges from 0= not hard at all,1= I pushed a tiny bit hard,2= I pushed a little hard,3= I pushed hard,4= I pushed very hard with higher scores indicating more severe straining. Participants recorded degree of straining for each BM in morning and evening eDiary. Scores during 4-week treatment period were calculated as mean of participant's non-missing, SBM associated straining scores during 4-week treatment period.
Secondary	Change From Baseline in 4-week Abdominal Bloating Daytime Symptoms Based on Evening Assessment	Baseline (14 days prior to randomization) to week 4	Participants recorded their assessment of abdominal bloating in the evening eDiary. Participants answered the question: How big and full did your tummy feel? on a scale, where: 0=none, 1=a tiny bit, 2=a little, 3=medium or 4=very, with a higher score indicating more severe bloating. Baseline value was the average of values collected 14 days before randomization. The 4-week daytime abdominal bloating symptoms were calculated as the average of non-missing scores reported in the evening eDiary during the treatment period. Change from Baseline was calculated as the 4-week daytime abdominal bloating score during the treatment period - daytime abdominal bloating score at baseline. A negative change from Baseline indicates improvement.
Secondary	Change From Baseline in 4-week Overall Complete Spontaneous Bowel Movement (CSBM) Frequency Rate (CSBMs Per Week)	Baseline (14 days prior to randomization and up to randomization) to week 4	SBM was defined as a 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. A CSBM was an SBM that was associated with a sense of complete evacuation. Participants recorded their assessment of the sensation of incomplete evacuation for each BM in the morning and evening eDiary. The 4-week overall CSBM frequency rate was calculated as \[total number of CSBMs in the analysis period/number of days in the analysis period\]\*7). Baseline value was based on values collected 14 days before randomization and up to randomization. Change from Baseline was calculated as the CSBM frequency rate during the 4-week treatment period - CSBM frequency rate at baseline. A positive change from Baseline indicates improvement.

Source ClinicalTrials.gov

Outcomes6

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 Treatment Period	Baseline (14 days prior to randomization and up to randomization) to week 4	ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use).	Spontaneous Bowel Movements per Week	MEAN
SECONDARY	Change From Baseline in 4-week Abdominal Pain Daytime Symptoms Based on Evening Assessment of Abdominal Pain Symptoms	Baseline (14 days prior to randomization) to week 4	ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use).	Units on a Scale	MEAN
SECONDARY	Change From Baseline in 4-week Stool Consistency	Baseline (14 days prior to randomization and up to randomization) to week 4	ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use).	Units on a Scale	MEAN
SECONDARY	Change From Baseline in 4-week Severity of Straining	Baseline (14 days prior to randomization and up to randomization) to week 4	ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use).	Units on a Scale	MEAN
SECONDARY	Change From Baseline in 4-week Abdominal Bloating Daytime Symptoms Based on Evening Assessment	Baseline (14 days prior to randomization) to week 4	ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use).	Units on a Scale	MEAN
SECONDARY	Change From Baseline in 4-week Overall Complete Spontaneous Bowel Movement (CSBM) Frequency Rate (CSBMs Per Week)	Baseline (14 days prior to randomization and up to randomization) to week 4	ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use).	CSBMs per Week	MEAN

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Treatment Period	Matching Placebo	1.447	Standard Deviation 1.376	Spontaneous Bowel Movements per Week
Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Treatment Period	Linaclotide Dose A	1.991	Standard Deviation 2.349	Spontaneous Bowel Movements per Week
Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Treatment Period	Linaclotide Dose B	2.298	Standard Deviation 2.634	Spontaneous Bowel Movements per Week
Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Treatment Period	Linaclotide Dose C	2.678	Standard Deviation 2.774	Spontaneous Bowel Movements per Week
Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Treatment Period	Linaclotide Approved Adult Dose	3.222	Standard Deviation 2.194	Spontaneous Bowel Movements per Week
Change From Baseline in 4-week Abdominal Pain Daytime Symptoms Based on Evening Assessment of Abdominal Pain Symptoms	Matching Placebo	-0.654	Standard Deviation 0.789	Units on a Scale
Change From Baseline in 4-week Abdominal Pain Daytime Symptoms Based on Evening Assessment of Abdominal Pain Symptoms	Linaclotide Dose A	-0.709	Standard Deviation 0.977	Units on a Scale
Change From Baseline in 4-week Abdominal Pain Daytime Symptoms Based on Evening Assessment of Abdominal Pain Symptoms	Linaclotide Dose B	-0.565	Standard Deviation 0.861	Units on a Scale
Change From Baseline in 4-week Abdominal Pain Daytime Symptoms Based on Evening Assessment of Abdominal Pain Symptoms	Linaclotide Dose C	-0.648	Standard Deviation 0.948	Units on a Scale
Change From Baseline in 4-week Abdominal Pain Daytime Symptoms Based on Evening Assessment of Abdominal Pain Symptoms	Linaclotide Approved Adult Dose	-1.192	Standard Deviation 1.032	Units on a Scale

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	Matching Placebo	19
Treatment Period	STARTED	Linaclotide Dose A	29
Treatment Period	STARTED	Linaclotide Dose B	21
Treatment Period	STARTED	Linaclotide Dose C	24
Treatment Period	STARTED	Linaclotide Approved Adult Dose	8
Treatment Period	COMPLETED	Matching Placebo	18
Treatment Period	COMPLETED	Linaclotide Dose A	27
Treatment Period	COMPLETED	Linaclotide Dose B	19
Treatment Period	COMPLETED	Linaclotide Dose C	22
Treatment Period	COMPLETED	Linaclotide Approved Adult Dose	8

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events40

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
other	Diarrhoea	Gastrointestinal disorders	Matching Placebo	0	19
other	Diarrhoea	Gastrointestinal disorders	Linaclotide Dose A	4	29
other	Diarrhoea	Gastrointestinal disorders	Linaclotide Dose B	3	21
other	Diarrhoea	Gastrointestinal disorders	Linaclotide Dose C	2	24
other	Diarrhoea	Gastrointestinal disorders	Linaclotide Approved Adult Dose	1	8
other	Abdominal pain	Gastrointestinal disorders	Matching Placebo	1	19
other	Abdominal pain	Gastrointestinal disorders	Linaclotide Dose A	2	29
other	Abdominal pain	Gastrointestinal disorders	Linaclotide Dose B	3	21
other	Abdominal pain	Gastrointestinal disorders	Linaclotide Dose C	1	24
other	Abdominal pain	Gastrointestinal disorders	Linaclotide Approved Adult Dose	0	8

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Matching Placebo	0	19
Total, all-cause mortality	Linaclotide Dose A	0	29
Total, all-cause mortality	Linaclotide Dose B	0	21
Total, all-cause mortality	Linaclotide Dose C	0	24
Total, all-cause mortality	Linaclotide Approved Adult Dose	0	8
Total, other adverse events	Matching Placebo	3	19
Total, other adverse events	Linaclotide Dose A	6	29
Total, other adverse events	Linaclotide Dose B	5	21
Total, other adverse events	Linaclotide Dose C	3	24
Total, other adverse events	Linaclotide Approved Adult Dose	1	8

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38504394	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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