Portal HypertensionPhase 2NCT00737594
Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
A Phase 2 study testing Cobiprostone in people with Portal Hypertension, run by Sucampo Pharma Americas, LLC at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- Cobiprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is >= 18 years of age.
- Patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.
- Patient has clinical diagnosis of cirrhosis.
- Patient has undergone variceal banding.
Who cannot join
- Patient has a Child-Pugh score >12.
- Patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or Budd-Chiari syndrome.
- Variceal banding procedure was performed within 1 month of the screening visit.
- Patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.
- Patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.
- Patient has hepatocellular carcinoma that is being medically treated or is advanced.
Show all 9Show fewer
- Patient has impaired renal function (i.e., serum creatinine concentration >1.8 mg/dl)
- Patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.
- Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: A Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.
- Conditions
- Portal Hypertension
- Being tested
- Placebo, Cobiprostone
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Matching placebo
Matching placebo capsules for oral administration
CobiprostoneDrug
Also called Experimental product
Cobiprostone capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo TID | Placebo comparator | Participants receive matching placebo capsules three times daily (TID) Receives: Drug: Placebo |
| 12 mcg TID | Experimental | Participants receive 12 mcg Cobiprostone TID Receives: Drug: Cobiprostone |
| 18 mcg TID | Experimental | Participants receive 18 mcg Cobiprostone TID Receives: Drug: Cobiprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2009
- Study completionMar 2009
Why it stopped: Failure to enroll a suitable number of qualified subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sucampo Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Investigator, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737594
- Sponsor's protocol ID
- SPH0721
- Status last verified
- Feb 2016
- First submitted
- 15 Aug 2008
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
- ClinicalTrials.gov ID
- NCT00737594
- Acronym / sponsor ID
- SPH0721
- Conditions
- Portal Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to enroll a suitable number of qualified subjects.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Sucampo Pharmaceuticals, Inc.
- Study start
- Jul 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Aug 2008 (estimated)
- Results
- Posted 16 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo TID | Placebo comparator | Drug: PlaceboParticipants receive matching placebo capsules three times daily (TID) |
| 12 mcg TID | Experimental | Drug: CobiprostoneParticipants receive 12 mcg Cobiprostone TID |
| 18 mcg TID | Experimental | Drug: CobiprostoneParticipants receive 18 mcg Cobiprostone TID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is >= 18 years of age.
- Patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.
- Patient has clinical diagnosis of cirrhosis.
- Patient has undergone variceal banding.
Key exclusion criteria (9 listed)
- Patient has a Child-Pugh score >12.
- Patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or Budd-Chiari syndrome.
- Variceal banding procedure was performed within 1 month of the screening visit.
- Patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.
- Patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.
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 |
|---|---|---|
| PlaceboAlso: Matching placeboMatching placebo capsules for oral administration | Drug | Placebo TID |
| CobiprostoneAlso: Experimental productCobiprostone capsules for oral administration | Drug | 12 mcg TID, 18 mcg TID |
Primary outcome
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Investigator principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cobiprostone in people with Portal Hypertension, run by Sucampo Pharma Americas, LLC at 1 site in United States.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 Nov 2019. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 16 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment (time frame: 4 weeks). 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 18 Nov 2019.