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A Single Centre, Pilot Trial of YF476 in Patients With Chronic Atrophic Gastritis, Hypergastrinaemia and Type I Gastric Carcinoids


Phase 2
18 Years
N/A
Open (Enrolling by invite only)
Both
Chronic Atrophic Gastritis, Hypergastrinaemia, Type I Gastric Carcinoids

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Trial Information

A Single Centre, Pilot Trial of YF476 in Patients With Chronic Atrophic Gastritis, Hypergastrinaemia and Type I Gastric Carcinoids


Inclusion Criteria:



- Patients known to have gastric carcinoids associated with chronic atrophic gastritis
and hypergastrinaemia, and who attend the outpatient clinic of the investigator;

- Men, postmenopausal women, premenopausal women who have been sterilised by tubal
ligation, hysterectomy or bilateral oophrectomy, or premenopausal women using
reliable contraception: condom and spermicide or intrauterine device;

- Adults ≥ 18 years;

- Good general health; and

- Able to give fully-informed, written consent.

Exclusion Criteria:

- Women who are pregnant, lactating or using a steroid contraceptive;

- History of gastric surgery, apart from surgery for gastric carcinoids;

- Evidence of Zollinger-Ellison syndrome;

- Prolonged QTc interval (>450 msec);

- Certain medicines and herbal remedies taken during the 7 days before visit 1;

- Previous treatment with somatostatin; or

- Participation in other clinical trials of unlicensed medicines within the previous 3
months.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Visual assessment of the number of gastric carcinoids.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Malcolm Boyce, BSc FRCP FFPM

Investigator Role:

Study Director

Investigator Affiliation:

Trio Medicines Ltd.

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

T-008

NCT ID:

NCT01339169

Start Date:

January 2011

Completion Date:

July 2012

Related Keywords:

  • Chronic Atrophic Gastritis
  • Hypergastrinaemia
  • Type I Gastric Carcinoids
  • YF476
  • Hypergastrinaemia
  • Carcinoid Tumor
  • Gastritis
  • Gastritis, Atrophic
  • Atrophy

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