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| Name | Class |
|---|---|
| Ironwood Pharmaceuticals, Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| controlled arm | Placebo Comparator |
| |
| treatment arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | matching Placebo Capsules, Oral, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 12-week Abdominal Pain/Abdominal Discomfort Weekly Responder | 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. | Baseline and Weeks 1-12 during the Treatment Period |
| 12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder | 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. | Baseline and Weeks 1-12 during the Treatment Period |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Huntsville | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35019221 | Derived | Peng LH, Fang JY, Dai N, Shen XZ, Yang YL, Sun J, Yang YS. Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial. J Dig Dis. 2022 Feb;23(2):99-110. doi: 10.1111/1751-2980.13081. |
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Patients went through a 14 to 21-day Pretreatment Period during which they provided qualifying bowel habit and symptom severity assessments and rescue medicine usage through an electronic diary (eDiary). 1722 patients provided consents with 839 qualified to join th study.
Patient recruitment occurred over an 18-month period from July 2013 to January 2015 at 98 study centers (40 in China, 42 in the US, 10 in Australia, 5 in New Zealand, and 1 in Canada).
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| ID | Title | Description |
|---|---|---|
| FG000 | Linaclotide Arm | Linaclotide 290 ug capsules, oral, once daily |
| FG001 | Placebo Arm | matching placebo capsules, oral, once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Linaclotide |
| Drug |
Linaclotide 290 ug Capsules, Oral, once daily |
|
| Baseline and 12-week Treatment Period |
| Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate | 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. | Baseline and 12-week Treatment Period |
| Change From Baseline in 12-week Stool Consistency | 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]). | Baseline and 12-week Treatment Period |
| Change From Baseline in 12-week Severity of Straining | 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). | Baseline and 12-week Treatment Period |
| Change From Baseline in 12-week Abdominal Bloating | 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. | Baseline and 12-week Treatment Period |
| Change From Baseline in 12-week Abdominal Pain | 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. | Baseline and 12-week Treatment Period |
| Change From Baseline in 12-week Abdominal Discomfort | 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. | Baseline and 12-week Treatment Period |
| 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 | Principal Investigator |
| North Little Rock |
| Arkansas |
| United States |
| Research Site | Phoenix | Arkansas | United States |
| Research Site | Artesia | California | United States |
| Research Site | Chula Vista | California | United States |
| Research Site | Encino | California | United States |
| Research Site | North Hollywood | California | United States |
| Research Site | Orange | California | United States |
| Research Site | Riverside | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Boynton Beach | Florida | United States |
| Research Site | Brandon | Florida | United States |
| Research Site | Brooksville | Florida | United States |
| Research Site | Doral | Florida | United States |
| Research Site | Gainesville | Florida | United States |
| Research Site | Hialeah | Florida | United States |
| Research Site | Kissimmee | Florida | United States |
| Research Site | Lauderdale Lakes | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Miami Lakes | Florida | United States |
| Research Site | Addison | Illinois | United States |
| Research Site | Evansville | Indiana | United States |
| Research Site | Crowley | Louisiana | United States |
| Research Site | Monroe | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Chesterfield | Michigan | United States |
| Research Site | Wyoming | Michigan | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Billings | Montana | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | Great Neck | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Salisbury | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Franklin | Ohio | United States |
| Research Site | Mentor | Ohio | United States |
| Research Site | Greer | South Carolina | United States |
| Research Site | Chattanooga | Tennessee | United States |
| Research Site | Kingsport | Tennessee | United States |
| Research Site | Knoxville | Tennessee | United States |
| Research Site | Smyrna | Tennessee | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Webster | Texas | United States |
| Research Site | Ogden | Utah | United States |
| Research Site | Lynchburg | Virginia | United States |
| Research Site | Morgantown | West Virginia | United States |
| Research Site | Adelaide | Australia |
| Research Site | Brisbane | Australia |
| Research Site | Five Dock | Australia |
| Research Site | Malvern | Australia |
| Research Site | Maroubra | Australia |
| Research Site | Melbourne | Australia |
| Research Site | Parkville | Australia |
| Research Site | Vaughan | Ontario | Canada |
| Research Site | Beijing | China |
| Research Site | Changsha | China |
| Research Site | Chengdu | China |
| Research Site | Chongqing | China |
| Research Site | Guangzhou | China |
| Research Site | Hangzhou | China |
| Research Site | Harerbin | China |
| Research Site | Hefei | China |
| Research Site | Jinan | China |
| Research Site | Nanchang | China |
| Research Site | Qingdao | China |
| Research Site | Shanghai | China |
| Research Site | Shenyang | China |
| Research Site | Shijiazhuang | China |
| Research Site | Wuhan | China |
| Research Site | Xi'an | China |
| Research Site | Xiamen | China |
| Research Site | Auckland | New Zealand |
| Research Site | Christchurch | New Zealand |
| Research Site | Dunedin | New Zealand |
| Research Site | Tauranga | New Zealand |
| Research Site | Wellington | New Zealand |
| COMPLETED |
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| NOT COMPLETED |
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Intent to Treat (ITT) Population (all 839 randomized patients)
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| ID | Title | Description |
|---|---|---|
| BG000 | Linaclotide Arm | Linaclotide 290 ug capsules, oral, once daily |
| BG001 | Placebo Arm | matching placebo capsules, oral, once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| countries | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 12-week Abdominal Pain/Abdominal Discomfort Weekly Responder | 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. | Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an abdominal pain score or abdominal discomfort score for a particular Treatment Period week, the patient was not considered a responder for that week. | Posted | Number | Participants | Baseline and Weeks 1-12 during the Treatment Period |
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| Primary | 12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder | 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. | Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an IBS degree of relief score for a particular Treatment Period week, the patient was not considered a responder for that week. | Posted | Number | Participants | Baseline and Weeks 1-12 during the Treatment Period |
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| Secondary | Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate | 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. | Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values). | Posted | Least Squares Mean | Standard Error | CSBMs per Week | Baseline and 12-week Treatment Period |
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| Secondary | Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate | 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. | Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values). | Posted | Least Squares Mean | Standard Error | SBMs per Week | Baseline and 12-week Treatment Period |
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| Secondary | Change From Baseline in 12-week Stool Consistency | 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]). | Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values). | Posted | Least Squares Mean | Standard Error | Units on a Scale (BSFS) | Baseline and 12-week Treatment Period |
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| Secondary | Change From Baseline in 12-week Severity of Straining | 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). | Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values). | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline and 12-week Treatment Period |
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| Secondary | Change From Baseline in 12-week Abdominal Bloating | 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. | Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values). | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline and 12-week Treatment Period |
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| Secondary | Change From Baseline in 12-week Abdominal Pain | 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. | Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values). | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline and 12-week Treatment Period |
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| Secondary | Change From Baseline in 12-week Abdominal Discomfort | 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. | Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values). | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline and 12-week Treatment Period |
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Adverse event data were collected from July 2013 to May 2015 (12 weeks of safety data were collected). Includes serious adverse events that occurred on or after the date of the first dose of study drug and within 30 days of the last dose of study drug.
Of the 839 randomized patients, a total of 835 patients received at least one dose of double-blind study drug and were included in the Safety Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Linaclotide Arm | Linaclotide 290 ug capsules, oral, once daily | 4 | 416 | 56 | 416 | ||
| EG001 | Placebo Arm | matching placebo capsules, oral, once daily | 10 | 419 | 26 | 419 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Pericoronitis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment |
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| Multiple system atrophy | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 16.0 | Systematic Assessment |
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| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 16.0 | Systematic Assessment |
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| Bladder outlet obstruction | Renal and urinary disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA Version 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment |
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All data generated in this trial will be the property of AstraZeneca and Ironwood Pharmaceuticals, Inc. An integrated clinical and statistical report will be prepared at the completion of the trial. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator, AstraZeneca, and Ironwood Pharmaceuticals, Inc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Zeng | AstraZeneca | +86 21 6030 1867 | peter.zeng@astrazeneca.com |
| ID | Term |
|---|---|
| C523483 | linaclotide |
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| >= 65 years |
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| Male |
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| Canada |
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| Australia |
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| New Zealand |
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| United States |
|
Odds ratio for response rate (linaclotide : placebo) |
| No |
| Superiority or Other |
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