Portal HypertensionPhase 4NCT00534677
The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed
A Phase 4 study testing Terlipressin and Octreotide in people with Portal Hypertension and Cirrhosis, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension, Cirrhosis, Hematemesis
- What is being tested?
- Terlipressin and Octreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 sitePakistan
- Study dates
- May 2004to Jul 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age
Who cannot join
- Ulcerative esophagitis,
- Mallory Weiss tear,
- Bleeding gastric or duodenal ulcers,
- Bleeding from gastric varices or portal hypertensive gastropathy and
- Upper GI bleed as a result of thrombocytopenia or bleeding diathesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices
Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with Esophageal Variceal Bleed (EVB).
Read the detailed description
The effectiveness of combining Endoscopic treatment with Octreotide or Terlipressin has not been prospectively studied in esophageal variceal hemorrhage (EVH).
This prospective, randomized clinical trial will help us in better patient management more efficiently and cost effectively.
- Conditions
- Portal Hypertension, Cirrhosis, Hematemesis, Melena
- Being tested
- Terlipressin, Octreotide
- Keywords
- Variceal bleed, Cirrhosis, Vasoactive agents, Terlipressin, Octreotide, Safety & Efficacy
- Medical subject headings
- Hypertension, Portal, Fibrosis, Hematemesis, Melena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Also called Novapresin
2 mg stat \& then 1 mg q6h iv and Placebo of Octreotide
OctreotideDrug
Also called sandostatin
Octreotide 50mcg/hr infusion \& a placebo of Terlipressin
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Terlipressin |
| B | Active comparator | Not described Receives: Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & Efficacy
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startMay 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Shahab Abid, FCPS, FACG, Principal investigator, Aga Khan UniversityWasim Jafri, FRCP, FACG, Study director, Aga Khan UniversitySaeed S Hamid, FRCP, FACG, Study director, Aga Khan UniversitySalih Mohammad, FCPS; MACG, Study director, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534677
- Sponsor's protocol ID
- 297-Med/ERC-04
- Status last verified
- Sep 2007
- First submitted
- 24 Sep 2007
- Last updated
- 5 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices
- ClinicalTrials.gov ID
- NCT00534677
- Acronym / sponsor ID
- 297-Med/ERC-04
- Conditions
- Portal Hypertension, Cirrhosis, Hematemesis, Melena
- Keywords
- Variceal bleed, Cirrhosis, Vasoactive agents, Terlipressin, Octreotide, Safety & Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Jul 2005 (actual)
- First posted
- 26 Sep 2007 (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.
Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with Esophageal Variceal Bleed (EVB).
Detailed description
The effectiveness of combining Endoscopic treatment with Octreotide or Terlipressin has not been prospectively studied in esophageal variceal hemorrhage (EVH).
This prospective, randomized clinical trial will help us in better patient management more efficiently and cost effectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Terlipressin |
| B | Active comparator | Drug: Octreotide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age
Key exclusion criteria (5 listed)
- Ulcerative esophagitis,
- Mallory Weiss tear,
- Bleeding gastric or duodenal ulcers,
- Bleeding from gastric varices or portal hypertensive gastropathy and
- Upper GI bleed as a result of thrombocytopenia or bleeding diathesis.
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: Novapresin2 mg stat \& then 1 mg q6h iv and Placebo of Octreotide | Drug | A |
| OctreotideAlso: sandostatinOctreotide 50mcg/hr infusion \& a placebo of Terlipressin | Drug | B |
Primary outcome
Safety & Efficacy
Time frame: 5 days
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 5 Dec 2007.
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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.
Shahab Abid, FCPS, FACG principal investigator
Aga Khan University
Wasim Jafri, FRCP, FACG study director
Aga Khan University
Saeed S Hamid, FRCP, FACG study director
Aga Khan University
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 Octreotide in people with Portal Hypertension and Cirrhosis, 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 1 inclusion and 5 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 5 Dec 2007. 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. 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?
Safety & Efficacy (time frame: 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 5 Dec 2007.