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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 (LIN-MD-63)

This study is currently recruiting participants.
Verified July 2017 by Forest Laboratories
Sponsor:
ClinicalTrials.gov Identifier:
NCT02559817
First Posted: September 24, 2015
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Forest Laboratories
September 23, 2015
September 24, 2015
July 21, 2017
November 1, 2015
May 5, 2018   (Final data collection date for 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 to week 4 ]
Same as current
Complete list of historical versions of study NCT02559817 on ClinicalTrials.gov Archive Site
  • Change from baseline in 4-week abdominal pain daytime symptoms based on evening assessment of abdominal pain symptoms [ Time Frame: Baseline to week 4 ]
  • Change from baseline in 4-week stool consistency [ Time Frame: Baseline to week 4 ]
    Patients will use the modified Pediatric Bristol Stool Form Scale (p-BSFS) to rate their stool consistency on a 7-point ordinal scale from 1 (hard lumps) to 7 (watery stool).
  • Change from baseline in 4-week severity of straining [ Time Frame: Baseline to week 4 ]
    Patients will assess the degree of staining on an ordinal scale from 0 (not at all) to 4 (very hard).
  • Change from baseline in 4-week abdominal bloating daytime symptoms based on evening assessment [ Time Frame: Baseline to week 4 ]
  • Change from baseline in 4-week overall complete spontaneous bowel movement (CSBM) frequency rate (CSBMs per Week) [ Time Frame: Baseline to week 4 ]
  • Change from baseline in 4-week abdominal pain daytime symptoms based on evening assessment of abdominal pain symptoms [ Time Frame: Baseline to week 4 ]
  • Change from baseline in 4-week stool consistency [ Time Frame: Baseline to week 4 ]
    Patients will use the modified Pediatric Bristol Stool Form Scale (p-BSFS) to rate their stool consistency on a 7-point ordinal scale from 1 (hard lumps) to 7 (watery stool).
  • Change from baseline in 4-week severity of straining [ Time Frame: Baseline to week 4 ]
    Patients will asses the degree of staining on an ordinal scale from 0 (not at all) to 4 (very hard).
  • Change from baseline in 4-week abdominal bloating daytime symptoms based on evening assessment [ Time Frame: Baseline to week 4 ]
  • Change from baseline in 4-week overall complete spontaneous bowel movement (CSBM) frequency rate (CSBMs per Week) [ Time Frame: Baseline to week 4 ]
Not Provided
Not Provided
 
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 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome With Constipation
  • Drug: Linaclotide Dose A
    Other Name: Linzess
  • Drug: Linaclotide Dose B
    Other Name: Linzess
  • Drug: Linaclotide Dose C
    Other Name: Linzess
  • Drug: Linaclotide Approved Adult Dose
    Other Name: Linzess
  • Drug: Matching Placebo
    Other Name: Linzess
  • Experimental: Linaclotide Dose A

    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

    Intervention: Drug: Linaclotide Dose A
  • Experimental: Linaclotide Dose B

    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

    Intervention: Drug: Linaclotide Dose B
  • Experimental: Linaclotide Dose C

    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

    Intervention: Drug: Linaclotide Dose C
  • Experimental: Linaclotide Approved Adult Dose

    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

    Intervention: Drug: Linaclotide Approved Adult Dose
  • Placebo Comparator: Matching Placebo

    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

    Intervention: Drug: Matching Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
May 5, 2018
May 5, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

    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
  • 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:

    1. History of retentive posturing or excessive volitional stool retention
    2. History of painful or hard bowel movements (BMs)
    3. Presence of a large fecal mass in the rectum
    4. 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

Exclusion Criteria:

  • 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 or hospital-based disimpaction any time prior to randomization
  • Patient is unable to tolerate the placebo during rhe Screening Period
Sexes Eligible for Study: All
7 Years to 17 Years   (Child)
No
Contact: Clincial Trials Registry Team 877-277-8566 IR-CTRegistration@allergan.com
Canada,   United States
 
 
NCT02559817
LIN-MD-63
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Forest Laboratories
Forest Laboratories
Ironwood Pharmaceuticals, Inc.
Study Chair: Anna Muslin Forest Laboratories, LLC, an Allergan Affiliate
Forest Laboratories
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP