Trial · NCT02122471
12-Week Study of Plecanatide for CIC (The National CIC3 Study)
NCT02122471, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2019-03-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 12-Week Study of Plecanatide for CIC (The National CIC3 Study). Trials, record NCT02122471. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02122471
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 12-Week Study of Plecanatide for CIC (The National CIC3 Study)
- NCT number
- NCT02122471
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,410 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Chronic Idiopathic Constipation
- Interventions
- Plecanatide, Placebo
- First posted
- 2014-04-24
- Last updated
- 2019-05-28
- Results first posted
- 2019-03-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Durable Overall CSBM Responders, Mean Replacement Approach | 12-Week Treatment Period | The primary efficacy endpoint was measured by the number of durable overall CSBM responders over the 12-week Treatment Period. A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation. |
| Secondary | Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach | Baseline and 12 weeks | The change from baseline in the number of Complete Spontaneous Bowel Movements (CSBMs) over the 12-week Treatment Period was analyzed. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation. |
| Secondary | Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach | Baseline and 12 weeks | The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was analyzed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period. |
| Secondary | Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach | Baseline and 12 weeks | The change from baseline in the stool consistency score (i.e. BSFS) over the 12-week Treatment Period was analyzed. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly mean BSFS score per patient was derived from the BSFS entries reported during the Treatment Period in the Daily Symptom Diary. The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale \[BSFS\] from 1 to 7. 1. = separate hard lumps like nuts (difficult to pass) 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on its surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges (passed easily) 6. = fluffy pieces with ragged edges, a mushy stool 7. = watery, no solid pieces (entirely liquid) |
| Secondary | Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach | Baseline and 12 weeks | The change from baseline in the straining score over the 12-week Treatment Period was analyzed. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Durable Overall CSBM Responders, Mean Replacement Approach | 12-Week Treatment Period | The modified ITT population (1310 subjects) for primary outcome was ITT population minus 27 subjects eliminated from two OAI sites. The ITT population (1337) as described in the Participate Flow consisted of the randomized subjects (1410) excluding 73 non-index subjects. Index subjects were duplicate subjects appeared once in the ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach | Baseline and 12 weeks | A total of 1288 patients included in ITT-E population for secondary outcome which consisted of the randomized subjects (1410) excluding 95 duplicate subjects as described in the Participate Flow and 27 subjects eliminated from two OAI sites. | CSBMs per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach | Baseline and 12 weeks | A total of 1288 patients included in ITT-E population for secondary outcome which consisted of the randomized subjects (1410) excluding 95 duplicate subjects as described in the Participate Flow and 27 subjects eliminated from two OAI sites. | SBMs per week | MEAN |
| SECONDARY | Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach | Baseline and 12 weeks | A total of 1288 patients included in ITT-E population for secondary outcome which consisted of the randomized subjects (1410) excluding 95 duplicate subjects as described in the Participate Flow and 27 subjects eliminated from two OAI sites. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach | Baseline and 12 weeks | A total of 1288 patients included in ITT-E population for secondary outcome which consisted of the randomized subjects (1410) excluding 95 duplicate subjects as described in the Participate Flow and 27 subjects eliminated from two OAI sites. | score on a scale | 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 |
|---|---|---|---|---|---|
| Number of Durable Overall CSBM Responders, Mean Replacement Approach | Placebo | 57 | Participants | ||
| Number of Durable Overall CSBM Responders, Mean Replacement Approach | Plecanatide 3 mg | 88 | Participants | ||
| Number of Durable Overall CSBM Responders, Mean Replacement Approach | Plecanatide 6 mg | 88 | Participants | ||
| Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach | Placebo | Baseline | 1.41 | Standard Error 0.138 | CSBMs per week |
| Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach | Plecanatide 3 mg | Baseline | 2.34 | Standard Error 0.139 | CSBMs per week |
| Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach | Plecanatide 6 mg | Baseline | 2.19 | Standard Error 0.138 | CSBMs per week |
| Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach | Placebo | 12 weeks | 1.69 | Standard Error 0.159 | CSBMs per week |
| Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach | Plecanatide 3 mg | 12 weeks | 2.66 | Standard Error 0.162 | CSBMs per week |
| Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach | Plecanatide 6 mg | 12 weeks | 2.50 | Standard Error 0.159 | CSBMs per week |
| Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach | Placebo | Baseline | 1.55 | Standard Deviation 1.591 | SBMs per week |
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 | Placebo | 445 | |
| Overall Study | STARTED | Plecanatide 3 mg | 443 | |
| Overall Study | STARTED | Plecanatide 6 mg | 449 | |
| Overall Study | COMPLETED | Placebo | 406 | |
| Overall Study | COMPLETED | Plecanatide 3 mg | 392 | |
| Overall Study | COMPLETED | Plecanatide 6 mg | 405 | |
| Overall Study | NOT COMPLETED | Placebo | 39 | |
| Overall Study | NOT COMPLETED | Plecanatide 3 mg | 51 | |
| Overall Study | NOT COMPLETED | Plecanatide 6 mg | 44 |
Source ClinicalTrials.gov
Adverse events54
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 | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 466 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Plecanatide 3 mg | 15 | 467 | 15 |
| other | Diarrhoea | Gastrointestinal disorders | Plecanatide 6 mg | 21 | 469 | 25 |
| other | Headache | Nervous system disorders | Placebo | 9 | 466 | 10 |
| other | Headache | Nervous system disorders | Plecanatide 3 mg | 10 | 467 | 10 |
| other | Headache | Nervous system disorders | Plecanatide 6 mg | 10 | 469 | 10 |
| serious | Cardiac failure congestive | Cardiac disorders | Placebo | 0 | 466 | 0 |
| serious | Cardiac failure congestive | Cardiac disorders | Plecanatide 3 mg | 1 | 467 | 1 |
| serious | Cardiac failure congestive | Cardiac disorders | Plecanatide 6 mg | 0 | 469 | 0 |
| serious | Vertigo positional | Ear and labyrinth disorders | Placebo | 0 | 466 | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Plecanatide 3 mg | ||
| Total, all-cause mortality | Plecanatide 6 mg | ||
| Total, other adverse events | Placebo | 15 | 466 |
| Total, other adverse events | Plecanatide 3 mg | 25 | 467 |
| Total, other adverse events | Plecanatide 6 mg | 31 | 469 |
| Total, serious adverse events | Placebo | 8 | 466 |
| Total, serious adverse events | Plecanatide 3 mg | 8 | 467 |
| Total, serious adverse events | Plecanatide 6 mg | 4 | 469 |
Source ClinicalTrials.gov
Papers4
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.
GET https://conductscience.org/api/trials/v1/NCT02122471
GET https://conductscience.org/api/trials/v1/NCT02122471/results?page=2