Irritable Bowel Syndrome With ConstipationPhase 2LIN-MD-63NCT02559817
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
A Phase 2 study testing Linaclotide Dose A, Linaclotide Dose B and Linaclotide Dose C in people with Irritable Bowel Syndrome With Constipation, run by Forest Laboratories at 48 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation
- What is being tested?
- Linaclotide Dose A, Linaclotide Dose B and Linaclotide Dose C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 48 sitesin 2 countries
- Study dates
- 1 Nov 2015to 30 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient weighs at least 18 kg (39.7 lbs)
- Patient meets Rome III criteria for child/adolescent IBS: at least once per week for at least 2 months before Screening Visit, the patient 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:
- a) Improvement with defecation
- b) Onset associated with a change in frequency of stool
- c) Onset associated with a change in form (appearance) of stool
- Patient meets modified Rome III criteria for child/adolescent Functional Constipation (FC): For at least 2 months before the Screening Visit, the patient 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) in the toilet per week. In addition, at least once per week, patient meets 1 or more of the following:
Show all 13Show fewer
- a) History of retentive posturing or excessive volitional stool retention
- b) History of painful or hard bowel movements (BMs)
- c) Presence of a large fecal mass in the rectum
- d) History of large diameter stools that may obstruct the toilet
- Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-permitted rescue medicine
- Patient has an average of fewer than 3 spontaneous BMs (SBMs) per week during the 14 days before the randomization day and up to the randomization. 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
- Patient or parent/guardian/LAR or caregiver is compliant with eDiary by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit
Who cannot join
- Patient reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization
- Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses
- Patient has required manual disimpaction anytime prior to randomization or disimpaction during in-patient hospitalization within one year prior to randomization
- Patient is unable to tolerate the placebo during rhe Screening Period
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States46 sites
Advanced Research Center - Site 069
Anaheim, California, 92805
Asheboro Research Associates - Site 022
Asheboro, North Carolina, 27203
Children's Center for Digestive Health Care LLC
Atlanta, Georgia, 30342
Boys Town National Research Hospital
Boys Town, Nebraska, 68010
Coastal Pediatric Research
Charleston, South Carolina, 29414
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879
WCCT Global, LLC
Costa Mesa, California, 92626
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Cook Children's Medical Center
Fort Worth, Texas, 76104
HealthStar Research, LLC
Hot Springs, Arkansas, 71913
Texas Children's Hospital/Baylor College Medicine
Houston, Texas, 77030
Houston Clinical Research Associates
Houston, Texas, 77090
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
GI Associates and Endoscopy Center
Jackson, Mississippi, 39202
Children's Mercy Hospital
Kansas City, Missouri, 64108
Midwest Children Health Research Institute
Lincoln, Nebraska, 68505
Midwest Children Health Research Institute
Lincoln, Nebraska, 68516
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
ACTCA, Inc
Los Angeles, California, 90017
Children's Hospital Los Angeles
Los Angeles, California, 90027
Advanced Medical Research Center
Miami, Florida, 33135
Goryeb Children's Hospital
Morristown, New Jersey, 07962
Coastal Pediatrics Associates
Mt. Pleasant, South Carolina, 29464
Columbia University Medical Center and Morgan Stanley Children's Hospital of New York
New York, New York, 10032
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
IPS Research Company
Oklahoma City, Oklahoma, 73103
Center for Clinical Trials, LLC
Paramount, California, 90723
Methodist Medical Center
Peoria, Illinois, 61602
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236
Rhode Island Hospital
Providence, Rhode Island, 02903
Capital Pediatrics and Adolescent Center PLLC
Raleigh, North Carolina, 27609
Virginia Tech Carilion School of Medicine Pediatric Gastroenterology
Roanoke, Virginia, 24013
Sun Research Institute
San Antonio, Texas, 78215
University of California at San Francisco
San Francisco, California, 94143
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683
Willis-Knighton Physician Network
Shreveport, Louisiana, 71118
Certified Research Consultants Virgo/Carter Pediatrics
Silver Spring, Maryland, 20910
Montgomery Medical Inc.
Smithfield, Pennsylvania, 15478
Sleepcare Clinical Research Institute
Stockbridge, Georgia, 30281
Aurora Health Care, Aurora Medical Center in Summit
Summit, Wisconsin, 53066
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405
ClinPoint Trials
Waxahachie, Texas, 75165
Heartland Research Associates, LLC
Wichita, Kansas, 67205
Canada2 sites
Children's Hospital of Western Ontario
London, Ontario, N6A 5W9
Physician's Clinical Research Inc.
Vaughan, Ontario, L4L 4Y7
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, A Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (ie, Fulfill Rome III Criteria for Child/Adolescent IBS and Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation
The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years.
This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.
This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.
- Being tested
- Linaclotide Dose A, Linaclotide Dose B, Linaclotide Dose C, Linaclotide Approved Adult Dose, Matching Placebo
- Keywords
- Irritable Bowel Syndrome with Constipation in children, Linzess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linaclotide Dose ADrug
Also called Linzess
Linaclotide Dose BDrug
Also called Linzess
Linaclotide Dose CDrug
Also called Linzess
Linaclotide Approved Adult DoseDrug
Also called Linzess
Matching PlaceboDrug
Also called Linzess
| Study group | Role | What they receive |
|---|---|---|
| Linaclotide Dose A | Experimental | Taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.
Dose A: 18 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg
Dose A: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg
Dose A: 36 micrograms solid oral capsule in children 12-17 years of age Receives: Drug: Linaclotide Dose A |
| Linaclotide Dose B | Experimental | Taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.
Dose B: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg
Dose B: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg
Dose B: 72 micrograms solid oral capsule in children 12-17 years of age Receives: Drug: Linaclotide Dose B |
| Linaclotide Dose C | Experimental | Taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.
Dose C: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg
Dose C: 145 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg
Dose C: 145 micrograms solid oral capsule in children 12-17 years of age Receives: Drug: Linaclotide Dose C |
| Linaclotide Approved Adult Dose | Experimental | Taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.
Approved Adult Dose: 290 micrograms solid oral capsule in children 12-17 years of age Receives: Drug: Linaclotide Approved Adult Dose |
| Matching Placebo | Placebo comparator | Taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast
Placebo liquid oral solution or placebo solid oral capsule in children 7-11 years of age
Placebo solid oral capsule in children 12-17 years of age Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Treatment Period
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.
Measured: Baseline (14 days prior to randomization and up to randomization) to week 4
Secondary outcomes (5)
Change From Baseline in 4-week Abdominal Pain Daytime Symptoms Based on Evening Assessment of Abdominal Pain Symptoms
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.
Measured: Baseline (14 days prior to randomization) to week 4
Change From Baseline in 4-week Stool Consistency
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.
Measured: Baseline (14 days prior to randomization and up to randomization) to week 4
Change From Baseline in 4-week Severity of Straining
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.
Measured: Baseline (14 days prior to randomization and up to randomization) to week 4
Change From Baseline in 4-week Abdominal Bloating Daytime Symptoms Based on Evening Assessment
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.
Measured: Baseline (14 days prior to randomization) to week 4
Change From Baseline in 4-week Overall Complete Spontaneous Bowel Movement (CSBM) Frequency Rate (CSBMs Per Week)
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.
Measured: Baseline (14 days prior to randomization and up to randomization) to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start1 Nov 2015
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome With ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ironwood Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Anna Muslin, Study chair, Forest Laboratories, LLC, an Allergan Affiliate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559817
- Sponsor's protocol ID
- LIN-MD-63
- Acronym
- LIN-MD-63
- Status last verified
- Dec 2020
- First submitted
- 23 Sep 2015
- Last updated
- 28 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Di Lorenzo C, Nurko S, Hyams JS, Rodriguez-Araujo G, Shakhnovich V, Saps M, Simon M. Safety and efficacy of linaclotide in children aged 7-17 years with irritable bowel syndrome with constipation. J Pediatr Gastroenterol Nutr. 2024 Mar;78(3):539-547. doi: 10.1002/jpn3.12103. Epub 2023 Dec 28.
PubMed 38504394
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, A Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (ie, Fulfill Rome III Criteria for Child/Adolescent IBS and Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation
- ClinicalTrials.gov ID
- NCT02559817
- Acronym / sponsor ID
- LIN-MD-63 / LIN-MD-63
- Keywords
- Irritable Bowel Syndrome with Constipation in children, Linzess
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Ironwood Pharmaceuticals, Inc.
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Posted 28 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years.
This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.
This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Linaclotide Dose A | Experimental | Drug: Linaclotide Dose ATaken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast. Dose A: 18 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg Dose A: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg Dose A: 36 micrograms solid oral capsule in children 12-17 years of age |
| Linaclotide Dose B | Experimental | Drug: Linaclotide Dose BTaken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast. Dose B: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg Dose B: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg Dose B: 72 micrograms solid oral capsule in children 12-17 years of age |
| Linaclotide Dose C | Experimental | Drug: Linaclotide Dose CTaken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast. Dose C: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to <35 kg Dose C: 145 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg Dose C: 145 micrograms solid oral capsule in children 12-17 years of age |
| Linaclotide Approved Adult Dose | Experimental | Drug: Linaclotide Approved Adult DoseTaken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast. Approved Adult Dose: 290 micrograms solid oral capsule in children 12-17 years of age |
| Matching Placebo | Placebo comparator | Drug: Matching PlaceboTaken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast Placebo liquid oral solution or placebo solid oral capsule in children 7-11 years of age Placebo solid oral capsule in children 12-17 years of age |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Patient weighs at least 18 kg (39.7 lbs)
- Patient meets Rome III criteria for child/adolescent IBS: at least once per week for at least 2 months before Screening Visit, the patient 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:
- a) Improvement with defecation
- b) Onset associated with a change in frequency of stool
- c) Onset associated with a change in form (appearance) of stool
Key exclusion criteria (4 listed)
- Patient reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization
- Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses
- Patient has required manual disimpaction anytime prior to randomization or disimpaction during in-patient hospitalization within one year prior to randomization
- Patient is unable to tolerate the placebo during rhe Screening Period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linaclotide Dose AAlso: Linzess | Drug | Linaclotide Dose A |
| Linaclotide Dose BAlso: Linzess | Drug | Linaclotide Dose B |
| Linaclotide Dose CAlso: Linzess | Drug | Linaclotide Dose C |
| Linaclotide Approved Adult DoseAlso: Linzess | Drug | Linaclotide Approved Adult Dose |
| Matching PlaceboAlso: Linzess | Drug | Matching Placebo |
Primary outcome
Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Treatment Period
Time frame: 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.
5 secondary outcomes
Change From Baseline in 4-week Abdominal Pain Daytime Symptoms Based on Evening Assessment of Abdominal Pain Symptoms
Time frame: Baseline (14 days prior to randomization) to week 4
Change From Baseline in 4-week Stool Consistency
Time frame: Baseline (14 days prior to randomization and up to randomization) to week 4
Change From Baseline in 4-week Severity of Straining
Time frame: Baseline (14 days prior to randomization and up to randomization) to week 4
Change From Baseline in 4-week Abdominal Bloating Daytime Symptoms Based on Evening Assessment
Time frame: Baseline (14 days prior to randomization) to week 4
Change From Baseline in 4-week Overall Complete Spontaneous Bowel Movement (CSBM) Frequency Rate (CSBMs Per Week)
Time frame: Baseline (14 days prior to randomization and up to randomization) to week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38504394Di Lorenzo C, Nurko S, Hyams JS, Rodriguez-Araujo G, Shakhnovich V, Saps M, Simon M. Safety and efficacy of linaclotide in children aged 7-17 years with irritable bowel syndrome with constipation. J Pediatr Gastroenterol Nutr. 2024 Mar;78(3):539-547. doi: 10.1002/jpn3.12103. Epub 2023 Dec 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Muslin study chair
Forest Laboratories, LLC, an Allergan Affiliate
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Linaclotide Dose A, Linaclotide Dose B and Linaclotide Dose C in people with Irritable Bowel Syndrome With Constipation, run by Forest Laboratories at 48 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Treatment Period (time frame: Baseline (14 days prior to randomization and up to randomization) to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02559817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.