We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC) (LIN-MD-62)

This study is currently recruiting participants.
Verified July 2017 by Forest Laboratories
Sponsor:
ClinicalTrials.gov Identifier:
NCT02559570
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
  Purpose

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children age 6-17 years This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 6-11 will receive oral liquid formulation and patients 12-17 will receive solid oral capsule or liquid oral solution.

Children ages 6-11 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 FC.


Condition Intervention Phase
Functional Constipation in Children Ages 6-17 Years Drug: Linaclotide Dose A Drug: Linaclotide Dose B Drug: Linaclotide Dose C Drug: Linaclotide Approved Adult Dose Drug: Matching Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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, Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
Actual Study Start Date: November 30, 2015
Estimated Study Completion Date: March 31, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 9 micrograms liquid oral solution in children 6-11 years of age with weight 18 to <35 kg

Dose A: 18 micrograms liquid oral solution in children 6-11 years of age with weight ≥ 35 kg

Dose A: 18 micrograms liquid oral solution or solid oral capsule in children 12-17 years of age

Drug: Linaclotide Dose A
Other Name: Linzess
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: 18 micrograms liquid oral solution in children 6-11 years of age with weight 18 to <35 kg

Dose B: 36 micrograms liquid oral solution in children 6-11 years of age with weight ≥ 35 kg

Dose B: 36 micrograms liquid oral solution or solid oral capsule in children 12-17 years of age

Drug: Linaclotide Dose B
Other Name: Linzess
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: 36 micrograms liquid oral solution in children 6-11 years of age with weight 18 to <35 kg

Dose C: 72 micrograms liquid oral solution in children 6-11 years of age with weight ≥ 35 kg

Dose C: 72 micrograms liquid oral solution or solid oral capsule in children 12-17 years of age

Drug: Linaclotide Dose C
Other Name: Linzess
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: 145 micrograms oral solution or solid oral capsule in children 12-17 years of age

Drug: Linaclotide Approved Adult Dose
Other Name: Linzess
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 in children 6-11 years of age

Placebo solid oral capsule or placebo liquid oral solution in children 12-17 years of age

Drug: Matching Placebo
Other Name: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient weighs at least 18 kg (39.7 lbs)
  • Patient meets modified Rome III criteria for child/adolescent 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 meets Rome III criteria for Child/Adolescent irritable bowel syndrome (IBS): At least once per week for at least 2 months before the Screening Visit, the patient has 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 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 the Screening Period
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559570


Contacts
Contact: Clinical Trial Registries Team 877-277-8566 IR-CTRegistration@allergan.com

  Show 58 Study Locations
Sponsors and Collaborators
Forest Laboratories
Ironwood Pharmaceuticals, Inc.
Investigators
Study Director: Anna Muslin Forest Laboratories, LLC, an Allergan Affiliate
  More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02559570     History of Changes
Other Study ID Numbers: LIN-MD-62
First Submitted: September 23, 2015
First Posted: September 24, 2015
Last Update Posted: July 21, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Forest Laboratories:
Functional constipation in children
Linzess

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms