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)
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| ClinicalTrials.gov Identifier: NCT01880424 |
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Recruitment Status :
Completed
First Posted : June 19, 2013
Results First Posted : September 27, 2016
Last Update Posted : September 27, 2016
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Irritable Bowel Syndrome With Constipation (IBS-C) | Drug: Placebo Drug: Linaclotide | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1722 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Study Start Date : | July 2013 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | May 2015 |
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: controlled arm |
Drug: Placebo
matching Placebo Capsules, Oral, once daily |
| Experimental: treatment arm |
Drug: Linaclotide
Linaclotide 290 ug Capsules, Oral, once daily |
- 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.
- 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.
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: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient has signed an Informed Consent Form(ICF).
- Patient Must not be pregnant or breastfeeding and agree to use birth control
- Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
- 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
- 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:
- Recent history of mushy or watery stools
- Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study
- Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
- Surgery to the gastrointestinal tract
- Usage of prohibited medications
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): NCT01880424
Show 82 study locations
| 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 |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01880424 |
| Other Study ID Numbers: |
ICP-103-307 |
| First Posted: | June 19, 2013 Key Record Dates |
| Results First Posted: | September 27, 2016 |
| Last Update Posted: | September 27, 2016 |
| Last Verified: | August 2016 |
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Irritable Bowel Syndrome Syndrome Constipation Disease Pathologic Processes Signs and Symptoms, Digestive Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Linaclotide Guanylyl Cyclase C Agonists Enzyme Activators Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |