Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI

NCT00587275 | Terminated Phase 2

• 1 other identifier: AST013
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. The patients will be switched to the other group (AST-120 or placebo)for the following four weeks.

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

Gastroesophageal Reflux Disease; GERD

Outcome Measures

Primary Outcomes (2)

• Reduction in the severity of GERD symptoms in patients receiving AST-120 assessed by comparing the symptom scores on the GSAS.

  8 weeks

• Safety endpoint is adverse events (AEs)deemed possibly, probably, or definitely related to treatment with investigational product.

  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.

  8 weeks

• Percent days without heartburn.

  8 weeks

• Percent daytime period without heartburn.

  8 weeks

• Percent change in SF-36 score.

  8 weeks

• Esophageal bilirubin levels as measured by Bilitec.

  8 weeks

Study Arms (2)

1

EXPERIMENTAL

AST-120, 2 gram sachets

Drug: AST-120

2

PLACEBO COMPARATOR

Celphere CP-305, stained to match appearance of AST-120 in 2g sachets.

Drug: Celphere CP-305

Interventions

AST-120 DRUG

Oral, sachet, 2 grams daily for 4 weeks

1

Celphere CP-305 DRUG

Oral, sachet, 2 grams daily for 4 weeks

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ocera Therapeutics: lead

Study Sites (1)

Southern Arizona VA Health Care System and University of Arizona Health Sciences Center

Tucson, Arizona, 85723, United States

Location

Related Publications (6)

• 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.

  PMID: 16482234 BACKGROUND

• Fennerty 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.

  PMID: 16303036 BACKGROUND

• Fass 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.

  PMID: 16011666 BACKGROUND

• Fukuda 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

  BACKGROUND

• Yamazaki Z, Fujimori T, Yoshimoto T, et al. Effect of Oral Adsorbent on Animal Models of Hepatic Failure 92(2):331-335, 1980

  BACKGROUND

• 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.

  PMID: 11142579 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

AST 120

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ronnie Fass, MD

  Southern Arizona VA Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: October 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

US (1)