Trial · NCT03763175
Efficacy and Safety of SYN-010 in IBS-C
NCT03763175, Phase 2, Terminated, Cedars-Sinai Medical Center; results first posted 2021-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of SYN-010 in IBS-C. Trials, record NCT03763175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03763175
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of SYN-010 in IBS-C
- NCT number
- NCT03763175
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- Cedars-Sinai Medical Center
- Conditions
- Irritable Bowel Syndrome With Constipation
- Interventions
- SYN-010 21 mg, SYN-010 42 mg, Placebo
- First posted
- 2018-12-04
- Last updated
- 2022-07-13
- Results first posted
- 2021-09-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Weekly Average Number of Completely Spontaneous Bowel Movements (CSBM) Compared to the 12-week Treatment Period | After completing 12-week course of SYN-010 | Subjects will record their daily bowel movements throughout the duration of the study. Change in weekly average number of CSBMs will be evaluated by comparing reported values pre- and post-treatment. |
| Secondary | Proportion of Overall Responders During the 12-week Treatment Period | After completing 12-week course of SYN-010 | An overall 12-week responder is defined as a patient with a weekly response in at least 50% of the weeks of treatment (6 of 12 weeks). A weekly response is defined as a decrease in the patient's weekly average score for worst abdominal pain in the past 24 hours of at least 30% compared to baseline and a stool frequency increase of 1 or more CSBMs per week compared with baseline. |
| Secondary | Proportion of Overall Stool Frequency Responders During the 12-week Treatment Period | After completing 12-week course of SYN-010 | An overall stool frequency responder is defined as a patient with a weekly stool frequency response in at least 50% of the weeks of treatment (6 of 12 weeks). A weekly stool frequency response is defined as a stool frequency increase of 1 or more CSBMs per week compared with baseline, with abdominal pain unchanged or improved compared with baseline. |
| Secondary | Proportion of Overall Abdominal Pain Intensity Responders During the 12-week Treatment Period | After completing 12-week course of SYN-010 | An overall abdominal pain intensity responder is defined as a patient with a weekly abdominal pain intensity response in at least 50% of the weeks of treatment (6 of 12 weeks). A weekly response abdominal pain intensity response is defined as a decrease in the patient's weekly average score for worst abdominal pain in the past 24 hours of at least 30% compared to baseline, with stool frequency unchanged or improved compared with baseline. |
| Secondary | Proportion of Overall Bloating Responders During the 12-week Treatment Period | After completing 12-week course of SYN-010 | An overall bloating responder is defined as a patient with a weekly bloating response in at least 50% of the weeks of treatment (6 of 12 weeks). A weekly bloating response is defined as a weekly average bloating score of at least 30% improvement compared to baseline, with stool frequency unchanged or improved compared with baseline. |
| Secondary | Proportion of Patients Using Rescue Medication | After completing 12-week course of SYN-010 | Subjects will record their use of rescue medication throughout the study period. Proportion of patients using rescue medication after completing the 12-week course of treatment will be compared to those reporting usage at baseline screening period. |
| Other | Proportion of Patients With Adequate Relief | After completing 12-week course of SYN-010 | Outcome will be assessed by evaluating proportion of patients reporting adequate relief pre- and post-treatment on validated questionnaire. |
| Other | Mean Change From Baseline in the Area-under-the-curve (AUC) of Breath Methane Production, Based on the 120-minute Lactulose Breath Test. | After completing 12-week course of SYN-010 | Change in exhaled methane level as a potential predictor of constipation improvement will be evaluated by comparing lactulose breath tests pre- and post-treatment. |
| Other | Change From Baseline in Breath Methane Production Based on a Single-point Breath Methane Test | After completing course of SYN-010 | Change in exhaled methane level as a potential predictor of constipation improvement will be evaluated by comparing single-point breath tests pre- and post-treatment. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Weekly Average Number of Completely Spontaneous Bowel Movements (CSBM) Compared to the 12-week Treatment Period | After completing 12-week course of SYN-010 | Change from baseline in weekly average number of CSBMs at Weeks 1 through 12. Weekly average number of CSBMs = 7 x (sum of daily number of CSBMs)/ (number of days with CSBM assessment) for the specific week.~The analysis for the primary endpoint was performed using the analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates based on the full analysis set. The primary analysis was conducted using the observed values. | Weekly average CSBMs | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Overall Responders During the 12-week Treatment Period | After completing 12-week course of SYN-010 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Overall Stool Frequency Responders During the 12-week Treatment Period | After completing 12-week course of SYN-010 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Overall Abdominal Pain Intensity Responders During the 12-week Treatment Period | After completing 12-week course of SYN-010 | secondary outcomes measures were not analyzed as interim analysis showed that the study has not met its primary end point and the study was terminated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Overall Bloating Responders During the 12-week Treatment Period | After completing 12-week course of SYN-010 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patients Using Rescue Medication | After completing 12-week course of SYN-010 | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Proportion of Patients With Adequate Relief | After completing 12-week course of SYN-010 | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline in the Area-under-the-curve (AUC) of Breath Methane Production, Based on the 120-minute Lactulose Breath Test. | After completing 12-week course of SYN-010 | particles per million * min | MEAN | |
| OTHER_PRE_SPECIFIED | Change From Baseline in Breath Methane Production Based on a Single-point Breath Methane Test | After completing course of SYN-010 | secondary outcomes measures were not analyzed as interim analysis showed that the study has not met its primary end point and the study was terminated. | particles per million | MEAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Weekly Average Number of Completely Spontaneous Bowel Movements (CSBM) Compared to the 12-week Treatment Period | SYN-010 21 mg | 1.53 | Standard Error 0.32 | Weekly average CSBMs | |
| Change From Baseline in the Weekly Average Number of Completely Spontaneous Bowel Movements (CSBM) Compared to the 12-week Treatment Period | SYN-010 42 mg | 0.32 | Standard Error 0.32 | Weekly average CSBMs | |
| Change From Baseline in the Weekly Average Number of Completely Spontaneous Bowel Movements (CSBM) Compared to the 12-week Treatment Period | Placebo | 0.51 | Standard Error 0.33 | Weekly average CSBMs | |
| Proportion of Overall Responders During the 12-week Treatment Period | SYN-010 21 mg | 1 | Participants | ||
| Proportion of Overall Responders During the 12-week Treatment Period | SYN-010 42 mg | 2 | Participants | ||
| Proportion of Overall Responders During the 12-week Treatment Period | Placebo | 6 | Participants | ||
| Proportion of Overall Stool Frequency Responders During the 12-week Treatment Period | SYN-010 21 mg | 4 | Participants | ||
| Proportion of Overall Stool Frequency Responders During the 12-week Treatment Period | SYN-010 42 mg | 6 | Participants | ||
| Proportion of Overall Stool Frequency Responders During the 12-week Treatment Period | Placebo | 9 | Participants | ||
| Proportion of Overall Abdominal Pain Intensity Responders During the 12-week Treatment Period | SYN-010 21 mg | 4 | Participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SYN-010 21 mg | 20 | |
| Overall Study | STARTED | SYN-010 42 mg | 19 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | COMPLETED | SYN-010 21 mg | 19 | |
| Overall Study | COMPLETED | SYN-010 42 mg | 17 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | SYN-010 21 mg | 1 | |
| Overall Study | NOT COMPLETED | SYN-010 42 mg | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Insomnia | Psychiatric disorders | SYN-010 21 mg | 2 | 20 | 2 |
| other | Insomnia | Psychiatric disorders | SYN-010 42 mg | 0 | 19 | 0 |
| other | Insomnia | Psychiatric disorders | Placebo | 2 | 20 | 2 |
| other | Muscle Aches | Musculoskeletal and connective tissue disorders | SYN-010 21 mg | 2 | 20 | 2 |
| other | Muscle Aches | Musculoskeletal and connective tissue disorders | SYN-010 42 mg | 2 | 19 | 2 |
| other | Muscle Aches | Musculoskeletal and connective tissue disorders | Placebo | 3 | 20 | 3 |
| other | Metallic Taste, Paresthesia, Dizziness | Nervous system disorders | SYN-010 21 mg | 1 | 20 | 1 |
| other | Metallic Taste, Paresthesia, Dizziness | Nervous system disorders | SYN-010 42 mg | 1 | 19 | 1 |
| other | Metallic Taste, Paresthesia, Dizziness | Nervous system disorders | Placebo | 1 | 20 | 1 |
| other | Abdominal Pain, Bloating, Flatulence, Nausea, Indigestion | Gastrointestinal disorders | SYN-010 21 mg | 4 | 20 | 6 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SYN-010 21 mg | 0 | 20 |
| Total, all-cause mortality | SYN-010 42 mg | 0 | 19 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, other adverse events | SYN-010 21 mg | 9 | 20 |
| Total, other adverse events | SYN-010 42 mg | 4 | 19 |
| Total, other adverse events | Placebo | 10 | 20 |
| Total, serious adverse events | SYN-010 21 mg | 0 | 20 |
| Total, serious adverse events | SYN-010 42 mg | 1 | 19 |
| Total, serious adverse events | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers22
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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