Trial · NCT03268811
A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302
NCT03268811, Phase 3, Completed, Shire; results first posted 2022-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302. Trials, record NCT03268811. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03268811
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302
- NCT number
- NCT03268811
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 9 participants, actual
- Lead sponsor
- Shire
- Conditions
- Short Bowel Syndrome
- Interventions
- Teduglutide
- First posted
- 2017-08-31
- Last updated
- 2022-05-24
- Other registries' IDs
- eudract:2021-005404-36
- Results first posted
- 2022-05-24
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline up to follow-up (up to 50 months) | An Adverse Event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs whose onset occurred, severity worsened or intensity increased after receiving the investigational product (IP) in the core study (SHP633-302 \[NCT02980666\]) or this extension study. Number of participants with TEAEs were reported. Baseline refers to the baseline value of the core study (SHP633-302 \[NCT02980666\]). |
| Primary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | From Baseline up to follow-up (up to 50 months) | Vital sign assessments included pulse rate, blood pressure (systolic and diastolic blood pressure) and body temperature. Number of participants with clinically significant abnormalities in vital signs which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 \[NCT02980666\]). |
| Primary | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | From Baseline up to follow-up (up to 50 months) | Clinical laboratory parameters included biochemistry, hematology and urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 \[NCT02980666\]). |
| Primary | Percent Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: (Total urine output over 48 hours / 2) / body weight (kilogram \[kg\]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF). Percent change from baseline in average total urine output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 \[NCT02980666\]). |
| Primary | Percent Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2). Percent change from baseline in average number of stools per day at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 \[NCT02980666\]). |
| Primary | Percent Change From Baseline in Average Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average stool/mixed stool diaper weight (gram per kilogram per day \[g/kg/day\]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day). Percent change from baseline in average stool/mixed stool diaper weight at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 \[NCT02980666\]). |
| Primary | Percent Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The body weight was used to calculate the average total ostomy output per day (mL/kg/day) using a formula analogous to that used to calculate the average daily urine output. Percent change from baseline in average total ostomy output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 \[NCT02980666\]). |
| Primary | Percent Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid. Baseline refers to the baseline value of the core study (SHP633-302 \[NCT02980666\]). A negative change from baseline indicates improvement. |
| Primary | Number of Participants With Anti-drug Antibodies (ADAs) (Including Neutralizing Antibodies) at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | Number of participants with ADAs (including NAbs) to teduglutide were used to summarize the presence of antibodies. The participants who tested positive only for ADAs (including NAbs) were reported. Baseline refers to the baseline value of the core study (SHP633-302 \[NCT02980666\]). |
| Primary | Number of Participants With Clinically Significant Changes in Gastrointestinal (GI) Specific Testing | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | GI specific testing included colonoscopy or sigmoidoscopy, abdominal ultrasound, fecal occult blood testing, upper GI series with small bowel follow-through (UGI/SBFT). Number of participants with clinically significant changes findings in gastrointestinal specific testing were reported. Baseline refers to the baseline value of the core study (SHP633-302 \[NCT02980666\]). |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline up to follow-up (up to 50 months) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in Vital Signs | From Baseline up to follow-up (up to 50 months) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | From Baseline up to follow-up (up to 50 months) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Percent change | MEAN |
| PRIMARY | Percent Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Percent change | MEAN |
| PRIMARY | Percent Change From Baseline in Average Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Percent change | MEAN |
| PRIMARY | Percent Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. Here, 0 in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Percent change | MEAN |
| PRIMARY | Percent Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Percent change | MEAN |
| PRIMARY | Number of Participants With Anti-drug Antibodies (ADAs) (Including Neutralizing Antibodies) at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and number analyzed refer to participants evaluable for this outcome at given categories. 0 in number analyzed signifies that no participant was evaluable for specified category for the specified group. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Gastrointestinal (GI) Specific Testing | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 \[NCT02980666\] or SHP633-305 \[NCT03268811\]). Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group169
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Total Children (Aged: 1 to 15 Years) | 7 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Infants (Corrected Gestational Age: 4 to < 12 Months) | 2 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Total Children (Aged: 1 to 15 Years) | 0 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Total Children (Aged: 1 to 15 Years) | Biochemistry | 5 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Infants (Corrected Gestational Age: 4 to < 12 Months) | Biochemistry | 1 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Total Children (Aged: 1 to 15 Years) | Hematology | 1 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Infants (Corrected Gestational Age: 4 to < 12 Months) | Hematology | 0 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Total Children (Aged: 1 to 15 Years) | Urinalysis. | 0 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Infants (Corrected Gestational Age: 4 to < 12 Months) | Urinalysis. | 0 | Participants |
1 to 10 of 169Source ClinicalTrials.gov
See all 169 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total Children (Aged: 1 to 15 Years) | 7 | |
| Overall Study | STARTED | Infants (Corrected Gestational Age: 4 to < 12 Months) | 2 | |
| Overall Study | COMPLETED | Total Children (Aged: 1 to 15 Years) | 7 | |
| Overall Study | COMPLETED | Infants (Corrected Gestational Age: 4 to < 12 Months) | 1 | |
| Overall Study | NOT COMPLETED | Total Children (Aged: 1 to 15 Years) | 0 | |
| Overall Study | NOT COMPLETED | Infants (Corrected Gestational Age: 4 to < 12 Months) | 1 |
Source ClinicalTrials.gov
Adverse events208
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 | Anaemia | Blood and lymphatic system disorders | Total Children (Aged: 1 to 15 Years) | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 | 0 |
| other | Conjunctivitis allergic | Eye disorders | Total Children (Aged: 1 to 15 Years) | 1 | 7 | 2 |
| other | Conjunctivitis allergic | Eye disorders | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 | 0 |
| other | Eye discharge | Eye disorders | Total Children (Aged: 1 to 15 Years) | 1 | 7 | 1 |
| other | Eye discharge | Eye disorders | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 | 0 |
| other | Strabismus | Eye disorders | Total Children (Aged: 1 to 15 Years) | 1 | 7 | 1 |
| other | Strabismus | Eye disorders | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Total Children (Aged: 1 to 15 Years) | 1 | 7 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 | 0 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total Children (Aged: 1 to 15 Years) | 0 | 7 |
| Total, all-cause mortality | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 |
| Total, other adverse events | Total Children (Aged: 1 to 15 Years) | 7 | 7 |
| Total, other adverse events | Infants (Corrected Gestational Age: 4 to < 12 Months) | 2 | 2 |
| Total, serious adverse events | Total Children (Aged: 1 to 15 Years) | 7 | 7 |
| Total, serious adverse events | Infants (Corrected Gestational Age: 4 to < 12 Months) | 2 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37364133 | DERIVED |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants With Clinically Significant Changes in Gastrointestinal (GI) Specific Testing | Trial comparisons |
| Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants With Clinically Significant Abnormalities in Vital Signs | Trial comparisons |
| Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): deaths from any cause | Trial comparisons |
| Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): serious adverse events | Trial comparisons |
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/NCT03268811
GET https://conductscience.org/api/trials/v1/NCT03268811/registered?page=2