HemorrhagePhase 4NCT00369694
Short Course Terlipressin for Control of Acute Variceal Bleeding
A Phase 4 study testing Terlipressin and Terlipressin & then Dummy in people with Hemorrhage and Esophageal Varices, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as 72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to moderate risk variceal bleed patients and hence… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemorrhage, Esophageal Varices, Portal Hypertension
- What is being tested?
- Terlipressin and Terlipressin & then Dummy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2006to Aug 2008
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute esophageal variceal bleed
- Liver cirrhosis
- Child's score </= 11
Who cannot join
- Patient on Mechanical ventilator and or ionotropic support
- Active angina, Recent Myocardial infarction or dynamic EKG changes
- Failure to control variceal bleed on initial endoscopy
- Gastric variceal bleed
- Spontaneous bacterial peritonitis at presentation
- Hepatocellular carcinoma or other liver metastatic malignancy
- Portal vein thrombosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed
The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as 72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to moderate risk variceal bleed patients and hence can save cost and may decrease length of hospital stay especially in the I.C.U or high dependency units.
Read the detailed description
The esophageal variceal bleeding is usually controlled with endoscopic treatment of variceal band ligation or sclerotherapy along with vasoactive drugs like Terlipressin or Octreotide. The risk of re-bleeding is highest during the initial 5 days from first presentation. Terlipressin is usually given for 3 days (72 hours). In this study we are trying to prove that among low to moderate risk patients, a short course of 1 day (24 hours) of Terlipressin is as effective as 3 days (72 hours) in preventing re-bleed once bleeding has been controlled with endoscopic therapy. This intervention will save 2 days cost incurred on the Terlipressin and may also help in decreasing the length of hospital stay in future.
- Conditions
- Hemorrhage, Esophageal Varices, Portal Hypertension
- Being tested
- Terlipressin, Terlipressin & then Dummy
- Keywords
- Esophageal varices, Portal Hypertension, Melena, Hematemesis, Gastrointestinal Hemorrhage, Terlipressin, Efficacy, Safety
- Medical subject headings
- Hemorrhage, Esophageal and Gastric Varices, Hypertension, Portal, Melena, Hematemesis, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Also called Novapressin
2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours
Terlipressin & then DummyDrug
Also called Novapressin
2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 72 hours of Terlipressin Receives: Drug: Terlipressin |
| 2 | Placebo comparator | 24 hours of Terlipressin \& then next 48 hours of Dummy of Terlipressin Receives: Drug: Terlipressin & then Dummy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variceal Re-bleed
Measured: 120 hours (5 Days)
Secondary outcomes (3)
All cause 30 days mortality
Measured: 30 days
30 days rebleed
Measured: 30 days from index bleed
Safety of Terlipressin
Measured: In Hospital safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ferozsons Laboratories Ltd.
- Investigators
- Saeed S Hamid, FRCP, FACG, Study chair, The Aga Khan University HospitalZahid SM Azam, MBBS, FCPS, Study director, The Aga Khan University HospitalWasim SM Jafri, FRCP, FACG, Study director, The Aga Khan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369694
- Sponsor's protocol ID
- 446-Med/ERC-05
- Status last verified
- Sep 2008
- First submitted
- 24 Aug 2006
- Last updated
- 25 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed
- ClinicalTrials.gov ID
- NCT00369694
- Acronym / sponsor ID
- 446-Med/ERC-05
- Conditions
- Hemorrhage, Esophageal Varices, Portal Hypertension
- Keywords
- Esophageal varices, Portal Hypertension, Melena, Hematemesis, Gastrointestinal Hemorrhage, Terlipressin, Efficacy, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Ferozsons Laboratories Ltd.
- Study start
- Aug 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 29 Aug 2006 (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.
The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as 72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to moderate risk variceal bleed patients and hence can save cost and may decrease length of hospital stay especially in the I.C.U or high dependency units.
Detailed description
The esophageal variceal bleeding is usually controlled with endoscopic treatment of variceal band ligation or sclerotherapy along with vasoactive drugs like Terlipressin or Octreotide. The risk of re-bleeding is highest during the initial 5 days from first presentation. Terlipressin is usually given for 3 days (72 hours). In this study we are trying to prove that among low to moderate risk patients, a short course of 1 day (24 hours) of Terlipressin is as effective as 3 days (72 hours) in preventing re-bleed once bleeding has been controlled with endoscopic therapy. This intervention will save 2 days cost incurred on the Terlipressin and may also help in decreasing the length of hospital stay in future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Terlipressin72 hours of Terlipressin |
| 2 | Placebo comparator | Drug: Terlipressin & then Dummy24 hours of Terlipressin \& then next 48 hours of Dummy of Terlipressin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute esophageal variceal bleed
- Liver cirrhosis
- Child's score </= 11
Key exclusion criteria (7 listed)
- Patient on Mechanical ventilator and or ionotropic support
- Active angina, Recent Myocardial infarction or dynamic EKG changes
- Failure to control variceal bleed on initial endoscopy
- Gastric variceal bleed
- Spontaneous bacterial peritonitis at presentation
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 |
|---|---|---|
| TerlipressinAlso: Novapressin2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours | Drug | 1 |
| Terlipressin & then DummyAlso: Novapressin2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours. | Drug | 2 |
Primary outcome
Variceal Re-bleed
Time frame: 120 hours (5 Days)
3 secondary outcomes
All cause 30 days mortality
Time frame: 30 days
30 days rebleed
Time frame: 30 days from index bleed
Safety of Terlipressin
Time frame: In Hospital safety
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 Sep 2008.
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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.
Saeed S Hamid, FRCP, FACG study chair
The Aga Khan University Hospital
Zahid SM Azam, MBBS, FCPS study director
The Aga Khan University Hospital
Wasim SM Jafri, FRCP, FACG study director
The Aga Khan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Terlipressin and Terlipressin & then Dummy in people with Hemorrhage and Esophageal Varices, run by Aga Khan University at 1 site in Pakistan.
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 7 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 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Variceal Re-bleed (time frame: 120 hours (5 Days)). It is what the study was designed to measure, not a finding.
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 Sep 2008.