Gastroesophageal Reflux Disease (GERD)Phase 2NCT00587275
Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI
A Phase 2 study testing AST-120 and Celphere CP-305 in people with Gastroesophageal Reflux Disease (GERD), run by Ocera Therapeutics at 1 site in United States.
Trial summary
The purpose of this project is to test how safe and how well AST-120, an investigational product, works in treating too much acid in the stomach. Patients will be randomly assigned to one of two groups, AST-120 or a placebo for the first four weeks of the study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- AST-120 and Celphere CP-305
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jun 2008
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight 40 to 136 kg (88 to 300 lbs)
- Recent history of GERD related symptoms (at least twice weekly) confirmed during screening.
- Recent history of 8 week PPI treatment without significant improvement
- Abnormal bilirubin level as assessed by Bilitec
- Normal esophageal pH value (pH<4.0 for <4.2% of the time calculated over a 24 hour period)
- Platelet count (thrombocytes) >100,000/µL
Show all 10Show fewer
- Normal Hgb and Hct levels
- Able and willing to comply with all protocol procedures for the planned duration of the study
- Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information.
- Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (hormonal contraceptives, intrauterine devices, spermicide and barrier). Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.
Who cannot join
- Concurrent GI or other pathology which could interfere with the course of the study (e.g., erosive esophagitis, malabsorption, cirrhosis, ascites, bleeding ulcer, diabetes, scleroderma, non-GI myopathy or neuropathy etc.) Note: patients with Barrett's esophagus (short segment defined as < 3 cm) can be included.
- Patients with cancer or undergoing chemotherapy for the treatment of cancer
- Patients with a history of upper GI surgery
- Patients with GERD complications such as stricture of the esophagus
- Contraindication to continued PPI treatment
- Patients requiring the concomitant use of NSAIDs for the duration of the study
Show all 13Show fewer
- Uncontrolled systemic disease
- Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose of medications for at least 6 months
- Other major physical or psychiatric illness in previous 6 months as determined by the treating physician
- Known hypersensitivity or contraindication to any component of the test product (study drug) or diagnostics used
- Participation in another study within eight (8) weeks prior to randomization
- Unable to attend all visits required by the protocol
- Pregnant, breast feeding, or planning to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Arizona VA Health Care System and University of Arizona Health Sciences Center
Tucson, Arizona, 85723
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Crossover Study to Assess the Efficacy of AST-120 in Patients With Gastroesophageal Reflux Disease (GERD) Who Continue to be Symptomatic on a Standard Dose of Proton Pump Inhibitor (PPI)
The purpose of this project is to test how safe and how well AST-120, an investigational product, works in treating too much acid in the stomach. Patients will be randomly assigned to one of two groups, AST-120 or a placebo for the first four weeks of the study. The patients will be switched to the other group (AST-120 or placebo)for the following four weeks.
Read the detailed description
This is a double-blind, randomized, placebo-controlled, crossover trial where 20 patients with confirmed persistent GERD symptoms (at least twice weekly) after a standard course of PPI, with abnormal bile reflux levels but normal esophageal acid exposure are randomized to initially receive either AST-120 or placebo for a period of 4 weeks after a two week screening period. After a washout period of one week, patients will cross over to the opposite blinded treatment.
The experimental drug AST-120 is composed of black, odorless spherical carbon particles in 2g sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose spheres, Celphere CP-305, stained to match the appearance of AST-120, in 2g sachets (aluminum foil pouches). Both AST-120 and placebo are oral (taken by mouth) preparations. Both are tasteless. Take the product, patients will tear open the sachet, drop the contents directly on their tongue and wash it down with 8 ounces of water.
Patients will continue to receive the previously prescribed PPI throughout the duration of the trial. In addition, patients will be allowed up to 6 Gelusil tablets daily as a "rescue medication".
Patients will be expected to participate in approximately 5 in-clinic visits. During these visits, patients will undergo a number of tests including: comprehensive physical, hematology panel, a urine pregnancy test for pre-menopausal females, completion of the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) and Short-Form-36 (SF-36)Quality of Life Form and an upper endoscopy will be performed to determine the extent of esophageal inflammation.
Patients will be allowed to continue on their previously prescribed PPI with no changes and may take up to 6 Gelusil tablets per day. The following therapies must be discontinued and should not be taken during the trial: H2receptor antagonists, NSAIDs, Baclofen and Antacids (OTC or prescription).
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- AST-120, Celphere CP-305
- Keywords
- Gastroesophageal Reflux Disease, GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-120Drug
Oral, sachet, 2 grams daily for 4 weeks
Celphere CP-305Drug
Oral, sachet, 2 grams daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AST-120, 2 gram sachets Receives: Drug: AST-120 |
| 2 | Placebo comparator | Celphere CP-305, stained to match appearance of AST-120 in 2g sachets. Receives: Drug: Celphere CP-305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the severity of GERD symptoms in patients receiving AST-120 assessed by comparing the symptom scores on the GSAS.
Measured: 8 weeks
Safety endpoint is adverse events (AEs)deemed possibly, probably, or definitely related to treatment with investigational product.
Measured: 8 weeks
Secondary outcomes (10)
Reduction in severity of GERD symptoms in patients receiving AST-120 assessed by patient self assessment using a daily diary.
Measured: 8 weeks
Percent days without heartburn.
Measured: 8 weeks
Percent daytime period without heartburn.
Measured: 8 weeks
Percent change in SF-36 score.
Measured: 8 weeks
Esophageal bilirubin levels as measured by Bilitec.
Measured: 8 weeks
Amount of rescue medication (Gelusil) taken per day.
Measured: 8 weeks
Changes in clinical laboratory tests from baseline.
Measured: 8 weeks
Prior and concomitant medications.
Measured: 8 weeks
Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature).
Measured: 8 weeks
GI tolerability (diarrhea, constipation, etc).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Terminated for lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocera Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronnie Fass, MD, Principal investigator, Southern Arizona VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587275
- Sponsor's protocol ID
- AST013
- Status last verified
- Jun 2014
- First submitted
- 21 Dec 2007
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Xu XR, Li ZS, Zou DW, Xu GM, Ye P, Sun ZX, Wang Q, Zeng YJ. Role of duodenogastroesophageal reflux in the pathogenesis of esophageal mucosal injury and gastroesophageal reflux symptoms. Can J Gastroenterol. 2006 Feb;20(2):91-4. doi: 10.1155/2006/498142.
PubMed 16482234Fennerty MB. Review article: alternative approaches to the long-term management of GERD. Aliment Pharmacol Ther. 2005 Dec;22 Suppl 3:39-44. doi: 10.1111/j.1365-2036.2005.02711.x.
PubMed 16303036Fass R, Shapiro M, Dekel R, Sewell J. Systematic review: proton-pump inhibitor failure in gastro-oesophageal reflux disease--where next? Aliment Pharmacol Ther. 2005 Jul 15;22(2):79-94. doi: 10.1111/j.1365-2036.2005.02531.x.
PubMed 16011666Fukuda Y, Takazoe M, Sugita A, et al. The treatment with an oral spherical adsorptive carbon (AST-120) improves anal fistula, PDAI and CDAI scores - A randomized double-blind placebo controlled trial. Abstract #765 presented at Digestive Disease Week meeting, Los Angeles, CA May 24, 2006
Yamazaki Z, Fujimori T, Yoshimoto T, et al. Effect of Oral Adsorbent on Animal Models of Hepatic Failure 92(2):331-335, 1980
Araki Y, Tsujikawa T, Andoh A, Sasaki M, Fujiyama Y, Bamba T. Therapeutic effects of an oral adsorbent on acute dextran sulphate sodium-induced colitis and its recovery phase in rats, especially effects of elimination of bile acids in gut lumen. Dig Liver Dis. 2000 Nov;32(8):691-8. doi: 10.1016/s1590-8658(00)80332-1.
PubMed 11142579
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Crossover Study to Assess the Efficacy of AST-120 in Patients With Gastroesophageal Reflux Disease (GERD) Who Continue to be Symptomatic on a Standard Dose of Proton Pump Inhibitor (PPI)
- ClinicalTrials.gov ID
- NCT00587275
- Acronym / sponsor ID
- AST013
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- Gastroesophageal Reflux Disease, GERD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated for lack of enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ocera TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Jan 2008 (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 project is to test how safe and how well AST-120, an investigational product, works in treating too much acid in the stomach. Patients will be randomly assigned to one of two groups, AST-120 or a placebo for the first four weeks of the study. The patients will be switched to the other group (AST-120 or placebo)for the following four weeks.
Detailed description
This is a double-blind, randomized, placebo-controlled, crossover trial where 20 patients with confirmed persistent GERD symptoms (at least twice weekly) after a standard course of PPI, with abnormal bile reflux levels but normal esophageal acid exposure are randomized to initially receive either AST-120 or placebo for a period of 4 weeks after a two week screening period. After a washout period of one week, patients will cross over to the opposite blinded treatment.
The experimental drug AST-120 is composed of black, odorless spherical carbon particles in 2g sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose spheres, Celphere CP-305, stained to match the appearance of AST-120, in 2g sachets (aluminum foil pouches). Both AST-120 and placebo are oral (taken by mouth) preparations. Both are tasteless. Take the product, patients will tear open the sachet, drop the contents directly on their tongue and wash it down with 8 ounces of water.
Patients will continue to receive the previously prescribed PPI throughout the duration of the trial. In addition, patients will be allowed up to 6 Gelusil tablets daily as a "rescue medication".
Patients will be expected to participate in approximately 5 in-clinic visits. During these visits, patients will undergo a number of tests including: comprehensive physical, hematology panel, a urine pregnancy test for pre-menopausal females, completion of the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) and Short-Form-36 (SF-36)Quality of Life Form and an upper endoscopy will be performed to determine the extent of esophageal inflammation.
Patients will be allowed to continue on their previously prescribed PPI with no changes and may take up to 6 Gelusil tablets per day. The following therapies must be discontinued and should not be taken during the trial: H2receptor antagonists, NSAIDs, Baclofen and Antacids (OTC or prescription).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AST-120AST-120, 2 gram sachets |
| 2 | Placebo comparator | Drug: Celphere CP-305Celphere CP-305, stained to match appearance of AST-120 in 2g sachets. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Body weight 40 to 136 kg (88 to 300 lbs)
- Recent history of GERD related symptoms (at least twice weekly) confirmed during screening.
- Recent history of 8 week PPI treatment without significant improvement
- Abnormal bilirubin level as assessed by Bilitec
- Normal esophageal pH value (pH<4.0 for <4.2% of the time calculated over a 24 hour period)
Key exclusion criteria (13 listed)
- Concurrent GI or other pathology which could interfere with the course of the study (e.g., erosive esophagitis, malabsorption, cirrhosis, ascites, bleeding ulcer, diabetes, scleroderma, non-GI myopathy or neuropathy etc.) Note: patients with Barrett's esophagus (short segment defined as < 3 cm) can be included.
- Patients with cancer or undergoing chemotherapy for the treatment of cancer
- Patients with a history of upper GI surgery
- Patients with GERD complications such as stricture of the esophagus
- Contraindication to continued PPI treatment
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 |
|---|---|---|
| AST-120Oral, sachet, 2 grams daily for 4 weeks | Drug | 1 |
| Celphere CP-305Oral, sachet, 2 grams daily for 4 weeks | Drug | 2 |
Primary outcome
Reduction in the severity of GERD symptoms in patients receiving AST-120 assessed by comparing the symptom scores on the GSAS.
Time frame: 8 weeks
Safety endpoint is adverse events (AEs)deemed possibly, probably, or definitely related to treatment with investigational product.
Time frame: 8 weeks
10 secondary outcomes
Reduction in severity of GERD symptoms in patients receiving AST-120 assessed by patient self assessment using a daily diary.
Time frame: 8 weeks
Percent days without heartburn.
Time frame: 8 weeks
Percent daytime period without heartburn.
Time frame: 8 weeks
Percent change in SF-36 score.
Time frame: 8 weeks
Esophageal bilirubin levels as measured by Bilitec.
Time frame: 8 weeks
Amount of rescue medication (Gelusil) taken per day.
Time frame: 8 weeks
Changes in clinical laboratory tests from baseline.
Time frame: 8 weeks
Prior and concomitant medications.
Time frame: 8 weeks
Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature).
Time frame: 8 weeks
GI tolerability (diarrhea, constipation, etc).
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Terminated for lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
- Background: PubMed 16482234Xu XR, Li ZS, Zou DW, Xu GM, Ye P, Sun ZX, Wang Q, Zeng YJ. Role of duodenogastroesophageal reflux in the pathogenesis of esophageal mucosal injury and gastroesophageal reflux symptoms. Can J Gastroenterol. 2006 Feb;20(2):91-4. doi: 10.1155/2006/498142.
- Background: PubMed 16303036Fennerty MB. Review article: alternative approaches to the long-term management of GERD. Aliment Pharmacol Ther. 2005 Dec;22 Suppl 3:39-44. doi: 10.1111/j.1365-2036.2005.02711.x.
- Background: PubMed 16011666Fass R, Shapiro M, Dekel R, Sewell J. Systematic review: proton-pump inhibitor failure in gastro-oesophageal reflux disease--where next? Aliment Pharmacol Ther. 2005 Jul 15;22(2):79-94. doi: 10.1111/j.1365-2036.2005.02531.x.
- BackgroundFukuda Y, Takazoe M, Sugita A, et al. The treatment with an oral spherical adsorptive carbon (AST-120) improves anal fistula, PDAI and CDAI scores - A randomized double-blind placebo controlled trial. Abstract #765 presented at Digestive Disease Week meeting, Los Angeles, CA May 24, 2006
- BackgroundYamazaki Z, Fujimori T, Yoshimoto T, et al. Effect of Oral Adsorbent on Animal Models of Hepatic Failure 92(2):331-335, 1980
- Background: PubMed 11142579Araki Y, Tsujikawa T, Andoh A, Sasaki M, Fujiyama Y, Bamba T. Therapeutic effects of an oral adsorbent on acute dextran sulphate sodium-induced colitis and its recovery phase in rats, especially effects of elimination of bile acids in gut lumen. Dig Liver Dis. 2000 Nov;32(8):691-8. doi: 10.1016/s1590-8658(00)80332-1.
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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.
Ronnie Fass, MD principal investigator
Southern Arizona VA Health Care System
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 AST-120 and Celphere CP-305 in people with Gastroesophageal Reflux Disease (GERD), run by Ocera Therapeutics 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 10 inclusion and 13 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 Jun 2014. 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?
The study was stopped early (reason given: Terminated for lack of enrollment). Results are not available in the source record.
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?
Reduction in the severity of GERD symptoms in patients receiving AST-120 assessed by comparing the symptom scores on the GSAS. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00587275, which also lists 6 linked publications.
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 Jun 2014.