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A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C) (D5630C00001)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880424
Recruitment Status : Completed
First Posted : June 19, 2013
Results First Posted : September 27, 2016
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE June 12, 2013
First Posted Date  ICMJE June 19, 2013
Results First Submitted Date  ICMJE April 28, 2016
Results First Posted Date  ICMJE September 27, 2016
Last Update Posted Date September 27, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
  • 12-week Abdominal Pain/Abdominal Discomfort Weekly Responder [ Time Frame: Baseline and Weeks 1-12 during the Treatment Period ]
    A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period. Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain. Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
  • 12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder [ Time Frame: Baseline and Weeks 1-12 during the Treatment Period ]
    A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was "Considerably relieved" or "Completely relieved") for at least 6 out of the 12 weeks of the Treatment Period. Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine.
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
  • Abdominal Pain/Abdominal Discomfort Weekly Responder rate [ Time Frame: 12 weeks ]
    A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria for at least 6 out of the first 12 weeks of the Treatment Period.
  • Irritable Bowel Syndrome (IBS) Degree of Relief Responder rate [ Time Frame: 12weeks ]
    A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
  • Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate [ Time Frame: Baseline and 12-week Treatment Period ]
    The change from baseline in 12-week CSBM frequency (i.e., average weekly CSBM frequency over the 12 weeks of the Treatment Period). A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as an SBM that is associated with a sense of complete evacuation.
  • Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate [ Time Frame: Baseline and 12-week Treatment Period ]
    The change from baseline in 12-week SBM frequency (i.e., average weekly SBM frequency over the 12 weeks of the Treatment Period). SBM is defined as a bowel movement without laxative use in the preceding 24 hours.
  • Change From Baseline in 12-week Stool Consistency [ Time Frame: Baseline and 12-week Treatment Period ]
    The change from baseline in 12-week stool consistency (i.e., the average of the non-missing Bristol Stool Form Scale [BSFS] score from the SBMs occurring during the 12-week Treatment Period). Consistency of each bowel movement was assessed daily by patients using the 7-point BSFS (1=Separate hard lumps like nuts [difficult to pass] to 7=Watery, no solid pieces [entirely liquid]).
  • Change From Baseline in 12-week Severity of Straining [ Time Frame: Baseline and 12-week Treatment Period ]
    The change from baseline in 12-week severity of straining (i.e., the average of the non-missing straining scores from the SBMs occurring during the 12-week Treatment Period). Severity of straining was assessed daily by patients on a 5-point ordinal scale (1=Not at all to 5=An extreme amount).
  • Change From Baseline in 12-week Abdominal Bloating [ Time Frame: Baseline and 12-week Treatment Period ]
    The change from baseline in 12-week abdominal bloating (i.e., the average of the non-missing daily abdominal bloating scores reported during the 12-week Treatment Period). Abdominal bloating (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating.
  • Change From Baseline in 12-week Abdominal Pain [ Time Frame: Baseline and 12-week Treatment Period ]
    The change from baseline in 12-week abdominal pain (i.e., the average of the non-missing daily abdominal pain scores reported during the 12-week Treatment Period). Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
  • Change From Baseline in 12-week Abdominal Discomfort [ Time Frame: Baseline and 12-week Treatment Period ]
    The change from baseline in 12-week abdominal discomfort (i.e., the average of the non-missing daily abdominal discomfort scores reported during the 12-week Treatment Period). Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
  • Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate [ Time Frame: 12weeks ]
  • Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate [ Time Frame: 12weeks ]
  • Change From Baseline in 12-week Stool Consistency [ Time Frame: 12weeks ]
  • Change From Baseline in 12-week Severity of Straining [ Time Frame: 12 weeks ]
  • Change From Baseline in 12-week Abdominal Bloating [ Time Frame: 12 weeks ]
  • Change From Baseline in 12-week Abdominal Pain [ Time Frame: 12 weeks ]
  • Change From Baseline in 12-week Abdominal Discomfort [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Official Title  ICMJE A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Brief Summary

This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand.

The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome With Constipation (IBS-C)
Intervention  ICMJE
  • Drug: Placebo
    matching Placebo Capsules, Oral, once daily
  • Drug: Linaclotide
    Linaclotide 290 ug Capsules, Oral, once daily
Study Arms  ICMJE
  • Placebo Comparator: controlled arm
    Intervention: Drug: Placebo
  • Experimental: treatment arm
    Intervention: Drug: Linaclotide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2015)
1722
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2013)
800
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient has signed an Informed Consent Form(ICF).
  2. Patient Must not be pregnant or breastfeeding and agree to use birth control
  3. Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
  4. Patient meets protocol-defined criteria for Irritable Bowel Syndrome with Constipation(IBS-C), including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria
  5. Patient meets protocol-defined eDiary completion Compliance and agrees to refrain from making any new, major life-style changes that may affect IBS-C symptoms

Exclusion Criteria:

  1. Recent history of mushy or watery stools
  2. Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study
  3. Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
  4. Surgery to the gastrointestinal tract
  5. Usage of prohibited medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   China,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01880424
Other Study ID Numbers  ICMJE ICP-103-307
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Ironwood Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator: Yunsheng Yang Chinese PLA General Hospital
Principal Investigator: Shutian Zhang Beijing Friendship Hospital
Principal Investigator: Zhaoshen Li Changhai Hospital Affiliated to Second Military Mecical University of Chinese PLA
Principal Investigator: Weifen Xie Changzheng Hospital Affiliated to Second Military Mecical University of Chinese PLA
Principal Investigator: Yaozong Yuan Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University
Principal Investigator: Youqing Xu Beijing Tiantan Hospital
Principal Investigator: Dongfeng Chen The Third Affiliated Hospital of Third Military Mecical University of Chinese PLA
Principal Investigator: Minhu Chen The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University
Principal Investigator: Yanqing Li Qilu Hospital of Shandong University
Principal Investigator: Xiaozhong Guo General Hospital of Shenyang Military Region of Chinese PLA
Principal Investigator: Youlin Yang First Affiliated Hospital of Harbin Medical University
Principal Investigator: Rongquan Wang The First Affiliated Hospital of Third Military Mecical University of Chinese PLA
Principal Investigator: Xiaohua Hou Union Hospital of Tongji Medical College of Huazhong University of Science & Technology
Principal Investigator: Liangping Li Sichuang Provincial People's Hospital
Principal Investigator: Chengwei Tang West China Hospital
Principal Investigator: Jianlin Ren Zhongshan Hospital Affiliated to Xiamen University
Principal Investigator: Xizhong Shen Shanghai Zhongshan Hospital
Principal Investigator: Yulan Liu Peking University People's Hospital
Principal Investigator: Dongmei Qian Beijing Tongren Hospital Affiliated to Capital Medical University
Principal Investigator: Huahong Wang Peking University First Hospital
PRS Account AstraZeneca
Verification Date August 2016

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