Trial · NCT01637272
Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome
NCT01637272, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2017-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome. Trials, record NCT01637272. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01637272
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome
- NCT number
- NCT01637272
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Dumping Syndrome
- Interventions
- SOM230
- First posted
- 2012-07-11
- Last updated
- 2017-05-10
- Other registries' IDs
- eudract:2012-001534-34
- Results first posted
- 2017-05-10
- Limitations and caveats
- All safety parameters were analyzed by study phase (sc/LAR)
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate in Plasma Glucose Level | at Month 3 (M3) | Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase |
| Secondary | Response Rate in Plasma Glucose Level | at Month 6 (M6), Month 12 (M12) | Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase) |
| Secondary | Response Rate in Pulse Rate | at baseline, M3, M6, M12 | Pulse rate was defined as percentage of patients with change in pulse rate \>=10 bpm from pre-OGTT to 30 minutes post OGTT. |
| Secondary | Response Rate in Hematocrit Levels | M3, M6, M12 | Percentage of patients with change in hematocrit \>= 3% from pre-OGTT to 30 minutes post OGTT. |
| Secondary | Insulin Levels During OGTT | M3, M6, M12 | Absolute insulin levels at the end of M3, M6, M12 |
| Secondary | Glucagon Levels During OGTT | M3, M6, M12 | Absolute glucagon levels at the end of Months 3, 6 \& 12 |
| Secondary | Glucagon-like Peptide 1 (GLP-1) Levels During OGTT | M3, M6, M12 | Absolute Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points. |
| Secondary | Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT | M3, M6, M12 | Absolute Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points. |
| Secondary | Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s) | M3, M6, M12 | Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. |
| Secondary | Dumping Severity Score (DSS) at the End of Months 3, 6 and 8 | M3, M6, M8 | Absolute Dumping Severity Score (DSS) scores at end of M3, M6 \& M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (\<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (\>90 minutes) after food ingestion). Early \& late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early \& late scores. DSS Range (min (absent) - max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate in Plasma Glucose Level | at Month 3 (M3) | The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. | percentage of participants | NUMBER |
| SECONDARY | Response Rate in Plasma Glucose Level | at Month 6 (M6), Month 12 (M12) | The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase. | percentage of participants | NUMBER |
| SECONDARY | Response Rate in Pulse Rate | at baseline, M3, M6, M12 | The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase. | Percentage of participants | NUMBER |
| SECONDARY | Response Rate in Hematocrit Levels | M3, M6, M12 | The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase. | Percentage of participants | NUMBER |
| SECONDARY | Insulin Levels During OGTT | M3, M6, M12 | The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase. | pmol/L | MEAN |
| SECONDARY | Glucagon Levels During OGTT | M3, M6, M12 | The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase. | pmol/L | MEAN |
| SECONDARY | Glucagon-like Peptide 1 (GLP-1) Levels During OGTT | M3, M6, M12 | The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase. | pmol/L | MEAN |
| SECONDARY | Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT | M3, M6, M12 | The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.~The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase. | pmol/L | MEAN |
| SECONDARY | Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s) | M3, M6, M12 | The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase. | scores on a scale | MEAN |
| SECONDARY | Dumping Severity Score (DSS) at the End of Months 3, 6 and 8 | M3, M6, M8 | The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase. | scores on a scale | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group184
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate in Plasma Glucose Level | SOM230 - 3 Months (sc) | 60.5 | 95% Confidence Interval 44.41 to 75.02 | percentage of participants | |
| Response Rate in Plasma Glucose Level | SOM230- 6 Months (LAR) | 36.4 | 95% Confidence Interval 20.40 to 54.88 | percentage of participants | |
| Response Rate in Plasma Glucose Level | SOM230 - 12 Months (Ext) | 39.4 | 95% Confidence Interval 22.91 to 57.86 | percentage of participants | |
| Response Rate in Pulse Rate | SOM230 - 3 Months (sc) | rate ≥ 10 bpm at baseline | 60.5 | Percentage of participants | |
| Response Rate in Pulse Rate | SOM230 - 6 Months (LAR) | rate ≥ 10 bpm at baseline | 24.2 | Percentage of participants | |
| Response Rate in Pulse Rate | SOM230 - 12 Months (Ext) | rate ≥ 10 bpm at baseline | 24.2 | Percentage of participants | |
| Response Rate in Pulse Rate | SOM230 - 3 Months (sc) | rate ≥ 10 bpm at post-baseline | 18.6 | Percentage of participants | |
| Response Rate in Pulse Rate | SOM230 - 6 Months (LAR) | rate ≥ 10 bpm at post-baseline | 36.4 | Percentage of participants | |
| Response Rate in Pulse Rate | SOM230 - 12 Months (Ext) | rate ≥ 10 bpm at post-baseline | 27.3 | Percentage of participants | |
| Response Rate in Hematocrit Levels | SOM230 - 3 Months (sc) | hematocrit >= 3% at baseline | 27.9 | Percentage of participants |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SOM230 | 43 | |
| Overall Study | Completed sc Phase | SOM230 | 33 | |
| Overall Study | Completed Core Phase (sc + LAR) | SOM230 | 31 | |
| Overall Study | Entered Extension Phase | SOM230 | 27 | |
| Overall Study | Completed Core But Did no Enter Ext.. | SOM230 | 4 | |
| Overall Study | COMPLETED | SOM230 | 23 | |
| Overall Study | NOT COMPLETED | SOM230 | 20 |
Source ClinicalTrials.gov
Adverse events128
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 | s.c. Phase | 0 | 43 | |
| other | Anaemia | Blood and lymphatic system disorders | LAR Phase | 2 | 33 | |
| other | Angina pectoris | Cardiac disorders | s.c. Phase | 3 | 43 | |
| other | Angina pectoris | Cardiac disorders | LAR Phase | 0 | 33 | |
| other | Palpitations | Cardiac disorders | s.c. Phase | 3 | 43 | |
| other | Palpitations | Cardiac disorders | LAR Phase | 0 | 33 | |
| other | Abdominal distension | Gastrointestinal disorders | s.c. Phase | 4 | 43 | |
| other | Abdominal distension | Gastrointestinal disorders | LAR Phase | 1 | 33 | |
| other | Abdominal pain | Gastrointestinal disorders | s.c. Phase | 7 | 43 | |
| other | Abdominal pain | Gastrointestinal disorders | LAR Phase | 7 | 33 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | s.c. Phase | ||
| Total, all-cause mortality | LAR Phase | ||
| Total, other adverse events | s.c. Phase | 31 | 43 |
| Total, other adverse events | LAR Phase | 25 | 33 |
| Total, serious adverse events | s.c. Phase | 6 | 43 |
| Total, serious adverse events | LAR Phase | 10 | 33 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| s.c. Phase vs LAR Phase: serious adverse events |
Source 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/NCT01637272
GET https://conductscience.org/api/trials/v1/NCT01637272/results?page=2