Trial · NCT01707225
Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD)
NCT01707225, Phase 1, Completed, Virginia Commonwealth University; results first posted 2016-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD). Trials, record NCT01707225. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01707225
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD)
- NCT number
- NCT01707225
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Gastrointestinal Bleeding
- Interventions
- Octreotide LAR Depot
- First posted
- 2012-10-16
- Last updated
- 2017-02-03
- Results first posted
- 2016-01-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Side-Effects | 24 weeks | Cardiovascular: Sinus bradycardia (19% to 25%) Hypertension (≤13%) conduction abnormalities (9% to 10%) Central nervous system: Fatigue (1% to 32%) headache (6% to 30%) malaise (16% to 20%) fever (16% to 20%) dizziness (5% to 20%) Pain (4% to 15%) Dermatologic: Pruritus (≤18%) Rash (15%; depot formulation) alopecia (≤13%) Endocrine \& metabolic: Hyperglycemia (2% to 27%) Gastrointestinal: Abdominal pain (5% to 61%) loose stools (5% to 61%) nausea (5% to 61%) diarrhea (34% to 58%) flatulence (≤38%) cholelithiasis (13% to 38%; length of therapy dependent) constipation (9% to 21%) vomiting (4% to 21%) Hematologic Anemia (5-15%) Local: Injection site pain (2% to 50%; dose and formulation related) Neuromuscular \& skeletal: Back pain (1% to 27%) arthropathy (8% to 19%) myalgia (≤18%) Renal Kidney Stones (5-15%) Respiratory: Upper respiratory infection (10% to 23%) Miscellaneous: flu symptoms (1% to 20%) |
| Secondary | Need for Blood Transfusion and Hospital Admission for GI Bleed | 24 weeks |
Source ClinicalTrials.gov
Outcomes2
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 Side-Effects | 24 weeks | participants | NUMBER | |
| SECONDARY | Need for Blood Transfusion and Hospital Admission for GI Bleed | 24 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
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 Side-Effects | Octreotide LAR Depot | 10 | 95% Confidence Interval 0 to 10 | participants | |
| Need for Blood Transfusion and Hospital Admission for GI Bleed | Octreotide LAR Depot | 10 | 95% Confidence Interval 0 to 10 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Octreotide LAR Depot | 10 | |
| Overall Study | COMPLETED | Octreotide LAR Depot | 10 | |
| Overall Study | NOT COMPLETED | Octreotide LAR Depot | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Octreotide LAR Depot | ||
| Total, other adverse events | Octreotide LAR Depot | 0 | 10 |
| Total, serious adverse events | Octreotide LAR Depot | 0 | 10 |
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 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/NCT01707225
GET https://conductscience.org/api/trials/v1/NCT01707225/registered