Trial · NCT00426153
Octreotide in Severe Polycystic Liver Disease
NCT00426153, Phase 2, Phase 3, Completed, Mayo Clinic; results first posted 2012-11-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Octreotide in Severe Polycystic Liver Disease. Trials, record NCT00426153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00426153
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Octreotide in Severe Polycystic Liver Disease
- NCT number
- NCT00426153
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 42 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Polycystic Kidney, Autosomal Dominant, Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Kidney, Polycystic, Abdominal Pain
- Interventions
- Octreotide, Placebo
- First posted
- 2007-01-24
- Last updated
- 2012-11-21
- Results first posted
- 2012-11-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Liver Volume | Baseline, 12 months | Percent change from baseline in liver volume, measured in milliliters by Magnetic Resonance Imaging (MRI)or Computed Tomography (CT) scans |
| Secondary | Percent Change in Renal Volume | Baseline, 12 months | Percent change from baseline in renal volume, measured in milliliters by MRI or CT scans |
| Secondary | Percent Change in Glomerular Filtration Rate (GFR) | Baseline, 12 months | Percent change from baseline in renal function/GFR, measured by clearance of iothalamate with monitoring of bladder emptying using ultrasound |
| Secondary | Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores | Baseline, 12 months | Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Liver Volume | Baseline, 12 months | percent change | MEAN | |
| SECONDARY | Percent Change in Renal Volume | Baseline, 12 months | 13 subjects were excluded from the analysis of the kidney data: 4 subjects had renal transplant before enrollment (3 in octreotide and 1 in placebo groups), 8 subjects had a diagnosis of ADPLD (4 in each group), 1 placebo subject has missing kidney data due to incomplete image coverage. | percent change | MEAN |
| SECONDARY | Percent Change in Glomerular Filtration Rate (GFR) | Baseline, 12 months | 13 subjects were excluded from the analysis of the kidney data: 4 subjects had renal transplant before enrollment (3 in octreotide and 1 in placebo groups), 8 subjects had a diagnosis of ADPLD (4 in each group), 1 placebo subject has missing kidney data due to incomplete image coverage. | percent change | MEAN |
| SECONDARY | Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores | Baseline, 12 months | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Liver Volume | Octreotide | -5.0 | Standard Deviation 6.77 | percent change | |
| Percent Change in Liver Volume | Placebo | 0.9 | Standard Deviation 8.33 | percent change | |
| Percent Change in Renal Volume | Octreotide | 0.25 | Standard Deviation 7.53 | percent change | |
| Percent Change in Renal Volume | Placebo | 8.61 | Standard Deviation 10.07 | percent change | |
| Percent Change in Glomerular Filtration Rate (GFR) | Octreotide | -5.1 | Standard Deviation 15.46 | percent change | |
| Percent Change in Glomerular Filtration Rate (GFR) | Placebo | -7.2 | Standard Deviation 13.21 | percent change | |
| Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores | Octreotide | Physical functioning at baseline | 74.8 | Standard Deviation 21.96 | units on a scale |
| Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores | Placebo | Physical functioning at baseline | 80.4 | Standard Deviation 23.73 | units on a scale |
| Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores | Octreotide | Physical functioning at 12 months | 77.0 | Standard Deviation 21.32 | units on a scale |
| Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores | Placebo | Physical functioning at 12 months | 82.1 | Standard Deviation 18.58 | units on a scale |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Octreotide | 28 | |
| Overall Study | STARTED | Placebo | 14 | |
| Overall Study | COMPLETED | Octreotide | 28 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | Octreotide | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events18
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 | Alopecia, moderate | Skin and subcutaneous tissue disorders | Octreotide | 1 | 28 | 1 |
| other | Alopecia, moderate | Skin and subcutaneous tissue disorders | Placebo | 0 | 14 | 0 |
| other | Diarrhea, Grade 1 | Gastrointestinal disorders | Octreotide | 17 | 28 | 17 |
| other | Diarrhea, Grade 1 | Gastrointestinal disorders | Placebo | 4 | 14 | 4 |
| other | Injection site granuloma | Skin and subcutaneous tissue disorders | Octreotide | 5 | 28 | 5 |
| other | Injection site granuloma | Skin and subcutaneous tissue disorders | Placebo | 0 | 14 | 0 |
| other | Injection site pain | Skin and subcutaneous tissue disorders | Octreotide | 21 | 28 | 21 |
| other | Injection site pain | Skin and subcutaneous tissue disorders | Placebo | 3 | 14 | 3 |
| other | Steatorrhea & weight loss | Gastrointestinal disorders | Octreotide | 1 | 28 | 1 |
| other | Steatorrhea & weight loss | Gastrointestinal disorders | Placebo | 0 | 14 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Octreotide | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Octreotide | 21 | 28 |
| Total, other adverse events | Placebo | 4 | 14 |
| Total, serious adverse events | Octreotide | 3 | 28 |
| Total, serious adverse events | Placebo | 0 | 14 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1RR024150 | Mayo Clinic Center for Translational Science Activities | RIZZA, ROBERT A. | MAYO CLINIC ROCHESTER | NATIONAL CENTER FOR RESEARCH RESOURCES | 2006 to 2011 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Octreotide vs Placebo: 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/NCT00426153
GET https://conductscience.org/api/trials/v1/NCT00426153/results?page=2