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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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This trial is primarily aimed to compare the effect and safety of electro-acupuncture and prucalopride for severe chronic constipation: if the short-term effect of electro-acupuncture is no inferior to prucalopride? Besides, the investigators will also mainly confirm the superiority of electro-acupuncture: if the effect of electro-acupuncture can last for 3~6 months? Then, assess the patients' acceptance of electro-acupuncture.
Study design: this trial is a multi-central randomized controlled trial which contains 14 centers. Random sequences will be generated by the clinical evaluating center of China Academy of Chinese Medical Sciences. Subjects are patients who have severe chronic constipation.
Sample size evaluation: Sample size will be based on the proportion of patients having mean complete spontaneous bowel movements (CSBMs) no less than 3 times per week. The proportion is 31.67% in our phase I clinical trial by using electro-acupuncture, and 30.9% in another trial by using prucalopride.The total sample size is 560.
Periods and primary outcome: participants will be assessed at baseline for 2 weeks, treated for 8 weeks, and followed up for 24 weeks. Primary outcome is the proportion of patients having mean CSBMs/week no less than 3 times over the latter 6-week treatment.
Quality control: the study is a randomized controlled trial; participants were included strictly; evaluators and statisticians are blinded; quality control officers of 3 different levels will supervise this trial.
Data management: this trial will use the Remote Dara Capture (RDC) system for data entering and Data Verification Plan (DVP) for data examining.
Statistical analysis: Intention-To-Treat (ITT) analysis will be used in this study. One-sided test (non-inferiority) will be used for testing the primary outcomes; meanwhile, two-sided test will be used for evaluating other outcomes. A P value equal to or less than 0.05 is considered to indicate statistical significance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electro-acupuncture | Experimental | Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 min, 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. |
|
| Prucalopride | Active Comparator | Prucalopride Succinate taken orally, 2mg/day in the morning before breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Procedure | Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 minutes, 5 times/week for the first 2 weeks and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8 | Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 3-8. Second, we got the number of patients with 3 or more mean weekly CSMBs. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%. Assessing time frame: the latter 6 weeks of treatment (weeks 3-8). | over weeks 3-8 (the latter 6-week treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 1-2, 11-12, 15-16, 19-20, 31-32. Second, we got the number of patients with 3 or more mean weekly CSMBs. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%. Assessing time frame: weeks 1-2, 11-12, 15-16, 19-20, 31-32. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | |
| Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu, Ph.D | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25055821 | Background | Liu B, Wang Y, Wu J, Mo Q, Wang W, He L, Yan S, Liu Z. Effect of electroacupuncture versus prucalopride for severe chronic constipation: protocol of a multi-centre, non-inferiority, randomised controlled trial. BMC Complement Altern Med. 2014 Jul 23;14:260. doi: 10.1186/1472-6882-14-260. | |
| 33273258 | Result |
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Data sharing study protocol, informed consent form, and statistical analysis plan are in the supplementary digital files with the clinical report. For statistical code and data sets, proposals should be directed to yanshiyan0927@sina.com, and requestors need to sign a data access agreement, if approved.
Within six months after the publication of the clinical report
For statistical code and data sets, proposals should be directed to yanshiyan0927@sina.com, and requestors need to sign a data access agreement, if approved.
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| ID | Title | Description |
|---|---|---|
| FG000 | Electro-acupuncture | Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 min, 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. acupuncture: Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 minutes, 5 times/week for the first 2 weeks and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks. |
| FG001 | Prucalopride | Prucalopride Succinate taken orally, 2mg/day in the morning before breakfast Prucalopride: Prucalopride Succinate will be taken orally at the dose of 2mg/day in the morning before breakfast. Each treatment cycle will be given for continuous 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| ||||||||||||||||||
| Treatment Period (8 Weeks ) |
| |||||||||||||||||||
| Follow-up Period (24 Weeks) |
|
Baseline analysis population was the recruited patients with baseline data. We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents with no baseline data. Therefore, they were not included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Electro-acupuncture | Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any. EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks. After the EA treatment is stopped, the participants will be followed up for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8 | Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 3-8. Second, we got the number of patients with 3 or more mean weekly CSMBs. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%. Assessing time frame: the latter 6 weeks of treatment (weeks 3-8). | We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the baseline analysis. | Posted | Number | percentage of participants | over weeks 3-8 (the latter 6-week treatment) |
|
the whole study period (34 weeks, from week -2 to week 32)
We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.
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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 | Electro-acupuncture | Electro-acupuncture (EA) at bilateral ST25, SP14 ,and ST37. Additionally, bilateral BL33 was used for severe straining if any; DU20 and DU24 were used for patients with anxiety and depression if any. EA treatment was lasted for 30 min, and EA treatment was taken 5 times/week for the first 2 weeks, and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks. After the EA treatment is stopped, the participants will be followed up for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac surgery due to myocardial infarction | Cardiac disorders | Non-systematic Assessment | This severe adverse event is unrelated to EA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhishun Liu | Guang'anmen Hospital, China Academy Chinese Medical Sciences | +86 010 88002331 | liuzhishun@aliyun.com |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| C406662 | prucalopride |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Prucalopride | Drug | Prucalopride Succinate will be taken orally at the dose of 2mg/day in the morning before breakfast. Each treatment cycle will be given for continuous 32 weeks. |
|
|
| over weeks 1-2, 11-12, 15-16, 19-20, 31-32. |
| the Proportion of Participants With ≥1 Increase in Mean Weekly CSBMs From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the increase in mean weekly CSBMs of each patient from baseline were calculated over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. Second, we got the number of patients with ≥1 increase in the mean weekly CSMBs from baseline. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%. Assessing time frame: weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
| Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
| Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
| the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8. | The change from baseline in the mean score of stool consistency of each SBM over weeks 1-2 and weeks 3-8. Assessing time: baseline, weeks 1-2 and weeks 3-8. Patients will self-report their stool consistency of each SBM according to the 7-type Bristol Stool Form Scale (scored by 1 to 7 respectively). Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3 and 4 were deemed as a normal stool. | over weeks 1-2, 3-8. |
| the Change From Baseline in Mean Score of Straining for Each SBM Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | The change from baseline in the mean score of straining of each SBM over weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Assessing time: baseline, weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Patients will self-report their straining degree of each SBM in the defecation diaries according to the following scale. 0 = not difficult; 1 = a little difficult, need some straining to defecate; 2 = difficult, need straining to defecate; 3 = very difficult, need hard straining to defecate. Higher scores mean a worse outcome. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
| Time to the First CSBMs | Abbreviation: CSBMs, complete spontaneous bowel movements. Time to the first CSBMs was counted by days. Rescue medicine or other measurements for constipation is not allowed to be used 48 hours before and after the first treatment for evaluating the time to the first complete spontaneous bowel movement. Participants were assessed after the first treatment until they having their first CSBMs. | from the time of their first treatment to the time they having their first CSBMs |
| Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life | The change from baseline of the score of Patient Assessment of Constipation Quality of Life (PAC-QOL) at week 4 and week 8. PAC-QOL is a self-report questionnaire to evaluate the quality of life in patients with constipation, which was distributed by Mapi Research Trust in France. This questionnaire contains 28 items including 4 basic parts of physical discomfort, worries and concerns, psychosocial discomfort, and satisfaction. We use the Chinese version in our trial. Assessing point: baseline, week 4 and week 8. The score of PAC-QOL ranged from 1 to 5 (1 indicates no discomfort or feeling very satisfied, 5 indicates extreme severity and always appears or feeling very dissatisfied). | week 4 and week 8 |
| Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
| Liu B, Wu J, Yan S, Zhou K, He L, Fang J, Fu W, Li N, Su T, Sun J, Zhang W, Yue Z, Zhang H, Zhao J, Zhou Z, Song H, Wang J, Liu L, Wang L, Lv X, Yang X, Liu Y, Sun Y, Wang Y, Qin Z, Zhou J, Liu Z. Electroacupuncture vs Prucalopride for Severe Chronic Constipation: A Multicenter, Randomized, Controlled, Noninferiority Trial. Am J Gastroenterol. 2021 May 1;116(5):1024-1035. doi: 10.14309/ajg.0000000000001050. |
| 41080507 | Derived | Gao S, Zhu L, Yao H, Fang J, Liu Z. Effect of electroacupuncture versus prucalopride for ultra-severe chronic constipation: Secondary analysis of a randomized controlled trial. Integr Med Res. 2026 Mar;15(1):101253. doi: 10.1016/j.imr.2025.101253. Epub 2025 Sep 12. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Prucalopride | Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks. Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Prucalopride | Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks. Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed. |
|
|
| Secondary | the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32. | Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 1-2, 11-12, 15-16, 19-20, 31-32. Second, we got the number of patients with 3 or more mean weekly CSMBs. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%. Assessing time frame: weeks 1-2, 11-12, 15-16, 19-20, 31-32. | We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis. | Posted | Number | percentage of participants | over weeks 1-2, 11-12, 15-16, 19-20, 31-32. |
|
|
|
| Secondary | the Proportion of Participants With ≥1 Increase in Mean Weekly CSBMs From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the increase in mean weekly CSBMs of each patient from baseline were calculated over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. Second, we got the number of patients with ≥1 increase in the mean weekly CSMBs from baseline. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%. Assessing time frame: weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis. | Posted | Number | percentage of participants | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
|
|
|
| Secondary | Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis. | Posted | Mean | 95% Confidence Interval | bowel movements | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
|
|
|
| Secondary | Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis. | Posted | Mean | 95% Confidence Interval | bowel movements | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
|
|
|
| Secondary | the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8. | The change from baseline in the mean score of stool consistency of each SBM over weeks 1-2 and weeks 3-8. Assessing time: baseline, weeks 1-2 and weeks 3-8. Patients will self-report their stool consistency of each SBM according to the 7-type Bristol Stool Form Scale (scored by 1 to 7 respectively). Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3 and 4 were deemed as a normal stool. | The number of participants providing data of stool consistency was 270 in EA group and 266 in prucalopride group. | Posted | Median | Inter-Quartile Range | score | over weeks 1-2, 3-8. |
|
|
|
| Secondary | the Change From Baseline in Mean Score of Straining for Each SBM Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | The change from baseline in the mean score of straining of each SBM over weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Assessing time: baseline, weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Patients will self-report their straining degree of each SBM in the defecation diaries according to the following scale. 0 = not difficult; 1 = a little difficult, need some straining to defecate; 2 = difficult, need straining to defecate; 3 = very difficult, need hard straining to defecate. Higher scores mean a worse outcome. | The number of participants providing data of straining was 271 in EA group and 266 in prucalopride group over weeks 1-2/3-8; The number of participants providing data of straining was 264 in EA group and 261 in prucalopride group over weeks 11-12/15-16/19-20/31-32. | Posted | Median | Inter-Quartile Range | score | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
|
|
|
| Secondary | Time to the First CSBMs | Abbreviation: CSBMs, complete spontaneous bowel movements. Time to the first CSBMs was counted by days. Rescue medicine or other measurements for constipation is not allowed to be used 48 hours before and after the first treatment for evaluating the time to the first complete spontaneous bowel movement. Participants were assessed after the first treatment until they having their first CSBMs. | The number of participants providing data of time to the first CSBMs was 272 in EA group and 266 in prucalopride group. | Posted | Median | Inter-Quartile Range | days | from the time of their first treatment to the time they having their first CSBMs |
|
|
|
| Secondary | Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life | The change from baseline of the score of Patient Assessment of Constipation Quality of Life (PAC-QOL) at week 4 and week 8. PAC-QOL is a self-report questionnaire to evaluate the quality of life in patients with constipation, which was distributed by Mapi Research Trust in France. This questionnaire contains 28 items including 4 basic parts of physical discomfort, worries and concerns, psychosocial discomfort, and satisfaction. We use the Chinese version in our trial. Assessing point: baseline, week 4 and week 8. The score of PAC-QOL ranged from 1 to 5 (1 indicates no discomfort or feeling very satisfied, 5 indicates extreme severity and always appears or feeling very dissatisfied). | The number of participants providing data of PAC-QOL was 261 in EA group and 260 in prucalopride group at week 4; The number of participants providing data of PAC-QOL was 261 in EA group and 257 in prucalopride group at week 8. | Posted | Mean | Standard Deviation | score | week 4 and week 8 |
|
|
|
| Other Pre-specified | Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | Posted | Number | percentage of participants | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
|
|
|
| Other Pre-specified | Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | Posted | Median | Inter-Quartile Range | tablet | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
|
|
|
| Other Pre-specified | Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. | Posted | Median | Inter-Quartile Range | ml | over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. |
|
|
|
| Post-Hoc | the Proportion of Overall CSBM Responders Over Weeks 1-8 | A weekly CSBM responder was defined as a patient who had ≥3 CSBMs for a given week and an increase from baseline of ≥1 CSBM for that same week. An overall CSBM responder was a patient who was a weekly CSBM responder for at least 6 of the 8 treatment weeks (75%). | Posted | Number | percentage of participants | over weeks 1-8 |
|
|
|
| Post-Hoc | the Proportion of Sustained CSBM Responder Over Weeks 1-8 | Posted | Number | percentage of participants | over weeks 1-8 |
|
|
|
| 1 |
| 277 |
| 49 |
| 277 |
| EG001 | Prucalopride | Prucalopride Succinate was taken orally, 2mg/day in the morning before breakfast for continuous 8 weeks. Participants took electrocardiograph (ECG) at day 7 of the 8th week. Participants would take prucalopride for additional 24 weeks if no significant ECG changes (such as prolonged QT intervals) showed. | 0 | 278 | 123 | 278 |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Faint | General disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cold | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Palpitation | Cardiac disorders | Non-systematic Assessment |
|
| Blood-stained stools due to diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| High uric acid | Renal and urinary disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle Aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sense of hunger | Gastrointestinal disorders | Non-systematic Assessment |
|
| Scapulohumeral periarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Foot sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neck and shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cervical spondylosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Local hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fear or nervous | Psychiatric disorders | Non-systematic Assessment |
|
| Dry mouth | Nervous system disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Emesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hyperplasia of mammary glands | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Upper limb numbness | Nervous system disorders | Non-systematic Assessment |
|
| Pyelonephritis | Renal and urinary disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Empyrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Arthrolithisis | Immune system disorders | Non-systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Distention in head | General disorders | Non-systematic Assessment |
|
| Leg Hurt | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Stomachache | Gastrointestinal disorders | Non-systematic Assessment |
|
| Knee Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Knee joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chest distress and short of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Elevated blood pressure | General disorders | Non-systematic Assessment |
|
| Toothache | General disorders | Non-systematic Assessment |
|
| Pharyngalgia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Soreness of waist | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Low back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lumbar disc herniation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Wrist sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Premature menstruation | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Fatty liver | Hepatobiliary disorders | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| weeks 15-16 |
|
| weeks 19-20 |
|
| weeks 31-32 |
|
| weeks 11-12 |
|
| weeks 15-16 |
|
| weeks 19-20 |
|
| weeks 31-32 |
|
| weeks 11-12 |
|
| weeks 15-16 |
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| weeks 19-20 |
|
| weeks 31-32 |
|
| weeks 11-12 |
|
| weeks 15-16 |
|
| weeks 19-20 |
|
| weeks 31-32 |
|
| week 3-8 |
|
|
| weeks 11-12 |
|
|
| weeks 15-16 |
|
|
| weeks 19-20 |
|
|
| weeks 31-32 |
|
|
| week 8 |
|
|
| weeks 11-12 |
|
| weeks 15-16 |
|
| weeks 19-20 |
|
| weeks 31-32 |
|
| weeks 11-12 |
|
| weeks 15-16 |
|
| weeks 19-20 |
|
| weeks 31-32 |
|
| weeks 11-12 |
|
| weeks 15-16 |
|
| weeks 19-20 |
|
| weeks 31-32 |
|