CirrhosisPhase 1/2NCT01188733
Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis
A Phase 1/2 study testing Long acting octreotide 10mg, Long acting Octreotide 30mg and Saline in people with Cirrhosis and Portal Hypertension, run by Mayo Clinic.
Trial summary
Octreotide is used to control variceal bleeding. However, octreotide has to be given through the vein and is effective for less than two hours. In this study the investigators determined whether a long-acting preparation of octreotide (Sandostatin LAR)given as an intra-muscular injection every month could decrease… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Portal Hypertension, Esophageal Varices
- What is being tested?
- Long acting octreotide 10mg, Long acting Octreotide 30mg and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jun 1998to Dec 2000
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis documented by biopsy, or suggested by characteristic features on abdominal imaging (nodular appearance, irregular contour) along with impaired synthetic liver function and thrombocytopenia and Child Turcotte Pugh Class A or B.
- presence of small esophageal varices, defined as varices < 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment
- age ≥ 18 years
Who cannot join
- pregnant, lactating or of child-bearing potential and not practicing acceptable method of birth control
- allergic to sandostatin
- high risk varices on endoscopy carried out within 3 months of assessment (large varices or red signs)
- Child Turcotte Pugh Class C cirrhosis
- hepatocellular carcinoma
- evidence of ongoing alcohol or illicit drug abuse within 6 months of the study
Show all 16Show fewer
- serum creatinine greater than 2 mg/dL
- platelet count below 50,000 per microliter
- prothrombin time 4 seconds or more greater than control
- human immunodeficiency virus (HIV) positive
- symptomatic gallstones
- previous history of upper gastrointestinal bleeding in the past 3 months, defined as hematemesis and/or melena
- previous history of variceal bleeding
- history of congestive heart failure , unstable angina, sustained ventricular tachycardia, or ventricular fibrillation
- use of any investigational drug within 1 month prior to screening and
- current use of beta blockers or long-acting nitrates, any other drug therapy known to have an influence on portal pressure (diuretics were allowed provided patients were on a stable dose for at least 30 days).
About this study
Official title: Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis
Octreotide is used to control variceal bleeding. However, octreotide has to be given through the vein and is effective for less than two hours.
In this study the investigators determined whether a long-acting preparation of octreotide (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.
- Conditions
- Cirrhosis, Portal Hypertension, Esophageal Varices
- Being tested
- Long acting octreotide 10mg, Long acting Octreotide 30mg, Saline
- Keywords
- portal hypertension, varices, cirrhosis, octreotide, somatostatin analog, Child Pugh Class A,B
- Medical subject headings
- Fibrosis, Hypertension, Portal, Esophageal and Gastric Varices, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long acting octreotide 10mgDrug
Also called Long-acting octreotide
Comparison of different doses
Long acting Octreotide 30mgDrug
Comparison of drug doses
SalineDrug
Comparison of drug doses
| Study group | Role | What they receive |
|---|---|---|
| Sandostatin LAR 10mg | Experimental | Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg Receives: Drug: Long acting octreotide 10mg |
| Sandostatin LAR 30mg | Experimental | Comparison of drug doses Receives: Drug: Long acting Octreotide 30mg |
| Saline | Placebo comparator | Saline control Receives: Drug: Saline |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJun 1998
- Primary completionJul 2000
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188733
- Sponsor's protocol ID
- 10-005739
- Status last verified
- Aug 2010
- First submitted
- 23 Aug 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT01188733
- Acronym / sponsor ID
- 10-005739
- Conditions
- Cirrhosis, Portal Hypertension, Esophageal Varices
- Keywords
- portal hypertension, varices, cirrhosis, octreotide, somatostatin analog, Child Pugh Class A,B
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 1998
- Primary completion
- Jul 2000 (actual)
- Study completion
- Dec 2000 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Octreotide is used to control variceal bleeding. However, octreotide has to be given through the vein and is effective for less than two hours.
In this study the investigators determined whether a long-acting preparation of octreotide (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sandostatin LAR 10mg | Experimental | Drug: Long acting octreotide 10mgSandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg |
| Sandostatin LAR 30mg | Experimental | Drug: Long acting Octreotide 30mgComparison of drug doses |
| Saline | Placebo comparator | Drug: SalineSaline control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cirrhosis documented by biopsy, or suggested by characteristic features on abdominal imaging (nodular appearance, irregular contour) along with impaired synthetic liver function and thrombocytopenia and Child Turcotte Pugh Class A or B.
- presence of small esophageal varices, defined as varices < 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment
- age ≥ 18 years
Key exclusion criteria (16 listed)
- pregnant, lactating or of child-bearing potential and not practicing acceptable method of birth control
- allergic to sandostatin
- high risk varices on endoscopy carried out within 3 months of assessment (large varices or red signs)
- Child Turcotte Pugh Class C cirrhosis
- hepatocellular carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long acting octreotide 10mgAlso: Long-acting octreotideComparison of different doses | Drug | Sandostatin LAR 10mg |
| Long acting Octreotide 30mgComparison of drug doses | Drug | Sandostatin LAR 30mg |
| SalineComparison of drug doses | Drug | Saline |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Long acting octreotide 10mg, Long acting Octreotide 30mg and Saline in people with Cirrhosis and Portal Hypertension, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2010.