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Somatostatin Analog
Octreotide Infusion Duration for Esophageal Varices (LOVARB Trial)
Phase 4
Recruiting
Led By Don Rockey, M.D
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence or suspicion of upper gastrointestinal bleed (GIB)
Upper GIB secondary to bleeding esophageal varices as shown by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days and 30 days
Awards & highlights
LOVARB Trial Summary
This trial found that 24-hour octreotide infusion was as effective and safe as 72-hour infusion after variceal banding in cirrhotic patients with active bleeding.
Who is the study for?
This trial is for adults with cirrhosis who have had an upper gastrointestinal bleed due to bleeding esophageal varices and need band ligation. They must be able to consent or have a representative do so. Excluded are those with GI cancer, recent variceal bleeding, prior shunt surgery, pregnancy, incarceration, severe recent illness, non-cirrhotic portal hypertension or octreotide allergy.Check my eligibility
What is being tested?
The study tests the effectiveness of two durations of octreotide infusion—24 hours versus 72 hours—in preventing rebleeding from esophageal varices after endoscopic banding in patients with liver cirrhosis.See study design
What are the potential side effects?
Octreotide may cause side effects such as abdominal pain, nausea, diarrhea or constipation, flatulence (gas), headache, dizziness or fatigue. Some people might experience injection site reactions like redness or discomfort.
LOVARB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I might have bleeding in my upper digestive tract.
Select...
I have had bleeding in my upper digestive tract due to swollen veins in my esophagus, treated with a specific procedure.
Select...
I have or might have cirrhosis.
LOVARB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days and 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days and 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Esophageal varices rebleed within 72-hours after control of initial bleed
Secondary outcome measures
Esophageal varices rebleed at 7 days and 30 days after control of initial bleed
Survival at 7 days and 30 days after control of initial bleed
Side effects data
From 2013 Phase 3 trial • 429 Patients • NCT0041206153%
Diarrhoea
51%
Stomatitis
48%
Fatigue
43%
Nausea
43%
Oedema peripheral
41%
Rash
32%
Vomiting
30%
Abdominal pain
30%
Decreased appetite
30%
Headache
27%
Anaemia
27%
Weight decreased
27%
Cough
27%
Dyspnoea
24%
Asthenia
23%
Hypokalaemia
20%
Pyrexia
20%
Dysgeusia
20%
Pruritus
20%
Hyperglycaemia
18%
Arthralgia
16%
Thrombocytopenia
15%
Pain in extremity
15%
Back pain
15%
Epistaxis
14%
Constipation
13%
Dizziness
13%
Aphthous stomatitis
13%
Flatulence
13%
Upper respiratory tract infection
13%
Urinary tract infection
11%
Dry skin
11%
Hypertension
10%
Musculoskeletal pain
10%
Abdominal pain upper
10%
Dry mouth
9%
Oropharyngeal pain
9%
Pneumonitis
9%
Nasopharyngitis
9%
Insomnia
9%
Flushing
8%
Neutropenia
8%
Dehydration
8%
Ascites
8%
Haemorrhoids
8%
Mouth ulceration
8%
Muscle spasms
8%
Musculoskeletal chest pain
8%
Erythema
8%
Hypercholesterolaemia
8%
Hypocalcaemia
7%
Leukopenia
7%
Chills
7%
Hypomagnesaemia
7%
Myalgia
7%
Blood creatinine increased
7%
Dysphagia
7%
Anxiety
7%
Depression
7%
Hyperlipidaemia
6%
Pleural effusion
6%
Abdominal distension
6%
Alopecia
6%
Sinusitis
6%
Dysuria
5%
Hypophosphataemia
5%
Pollakiuria
5%
Aspartate aminotransferase increased
5%
Bronchitis
5%
Onychoclasis
4%
Alanine aminotransferase increased
4%
Hyperhidrosis
4%
Small intestinal obstruction
4%
Pneumonia
4%
Dyspnoea exertional
3%
Pulmonary embolism
3%
General physical health deterioration
2%
Ileus
2%
Renal failure
1%
Colitis
1%
Carcinoid heart disease
1%
Angina pectoris
1%
Small intestinal stenosis
1%
Atrial septal defect
1%
Hypoglycaemia
1%
Cholecystitis acute
1%
Gastroenteritis
1%
Bone pain
1%
Flank pain
1%
Subileus
1%
Cardiac failure
1%
Cardiac failure congestive
1%
Carcinoid syndrome
1%
Abdominal pain lower
1%
Rectal haemorrhage
1%
Malaise
1%
Non-cardiac chest pain
1%
Cachexia
1%
Hypoxia
1%
Interstitial lung disease
1%
Syncope
1%
Renal failure acute
1%
Intestinal obstruction
1%
Cellulitis
1%
Hepatic failure
1%
Sepsis
1%
Metabolic acidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Octreotide
Everolimus + Octreotide
Everolimus Open Label
LOVARB Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 24-hour octreotide infusionExperimental Treatment1 Intervention
Patients will receive octreotide infusion over 24 hours
Group II: 72-hour octreotide infusionActive Control1 Intervention
Patients will receive octreotide infusion over 72 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Octreotide
2006
Completed Phase 4
~2360
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterOTHER
1,047 Previous Clinical Trials
1,053,639 Total Patients Enrolled
Ohio State UniversityOTHER
829 Previous Clinical Trials
505,583 Total Patients Enrolled
University of Florida HealthOTHER
9 Previous Clinical Trials
4,273 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have bleeding from stomach veins.I have had bleeding from enlarged veins in my esophagus or stomach in the last 3 months.People who are in prison.I might have bleeding in my upper digestive tract.I have used methods other than band ligation to stop GI bleeding.I can give my consent for the study or have someone legally authorized to do so on my behalf.I haven't had a heart attack, stroke, severe infection, breathing failure, or other serious illness in the last 6 weeks.You have a known or suspected allergy to octreotide.I have been diagnosed with cancer in my upper digestive system.I am 18 years old or older.I have had bleeding in my upper digestive tract due to swollen veins in my esophagus, treated with a specific procedure.I have or might have cirrhosis.I have had surgery to improve blood flow in my liver.I have high blood pressure in the veins of my esophagus, but I don't have cirrhosis.
Research Study Groups:
This trial has the following groups:- Group 1: 72-hour octreotide infusion
- Group 2: 24-hour octreotide infusion
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the population size of this research endeavor?
"In order to reach the 160-person quota, individuals who meet eligibility requirements can join this trial from multiple sites. For instance, The University of Texas at Austin and University of Florida Health both offer participation in this study."
Answered by AI
Could you provide an overview of the past trials involving Octreotide?
"Currently, 16 trials are ongoing to analyse the efficacy of Octreotide. Of these experiments, 5 have now entered Phase 3 and can be observed at a total of 792 different facilities; many located in Trabzon, Florida."
Answered by AI
Has Octreotide attained authorization from the FDA?
"On the safety scale of 1 to 3, octreotide was given a rating of 3 because this medical therapy has been approved following Phase 4 trials."
Answered by AI
How many locations are currently conducting the trial?
"Participants for this trial are being enrolled at The University of Texas at Austin in Austin, Texas, the University of Florida Health in Jacksonville, Florida, and Brooke Army Medical Center in Houston Oregon; amongst 8 other sites."
Answered by AI
To what kinds of ailments is Octreotide most frequently employed?
"Octreotide, a medication often used to treat octreotide, is also effective at managing long-term maintenance therapy and certain neoplasms including acromegaly and metastatic carcinoid tumors."
Answered by AI
Are there still opportunities for volunteers to join this trial?
"Affirmative. According to the information listed on clinicaltrials.gov, this medical trial is still recruiting participants with a first posting date of September 19th 2018 and most recent update occurring in December 2021. 160 test subjects are necessary for completion across 8 different centres."
Answered by AI
Who else is applying?
What site did they apply to?
The University of Texas at Austin
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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