Chronic Atrophic Gastritis (CAG)Phase 4NCT01474044
To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis (CAG)
A Phase 4 study testing Gastropylor Complex Capsules in people with Chronic Atrophic Gastritis (CAG), run by Xinjiang Biochemical Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and effective in the treatment of chronic atrophic gastritis (CAG). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Atrophic Gastritis (CAG)
- What is being tested?
- Gastropylor Complex Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 851 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Feb 2013
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years, male or female
- Histologically diagnosed CAG
- HP negative confirmed by gastric mucosal staining
- Signed an written informed consent
Who cannot join
- CAG with high-grade intraepithelial neoplasia
- Severe gastric mucosal erosion or bleeding needing treatment
- Active peptic ulcer, GERD, or esophageal stricture
- History of upper GI tract surgery
- History of malignant diseases
- With depression, anxiety neuroses, or hysteria
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- Heart failure (NYHA class lll or lV), liver disease (ALT ≥ 80 IU/L, AST ≥ 80 IU/L) or renal disease(Cr ≥ 150 ummol/L)
- Uncontrolled hypertension
- Uncontrolled diabetes
- Alcohol abuse
- Drug allergy
- Participated in another investigational study within 4 weeks prior to Visit 0
- Pregnancy, be a nursing mother or without conception control
- There is any concern by the investigator regarding the safe participation of the participant in the study or for any other reason; the investigator considers the participant inappropriate for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV Study to Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis
The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and effective in the treatment of chronic atrophic gastritis (CAG).
Read the detailed description
Till now, there is no ideal treatment to chronic atrophic gastritis(CAG). This study is try to find a possible treatment to CAG with Gastropyloric Complex Capsules.
- Conditions
- Chronic Atrophic Gastritis (CAG)
- Being tested
- Gastropylor Complex Capsules, Placebo Comparator
- Medical subject headings
- Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastropylor Complex CapsulesDrug
Also called Gastropyloric Extracts and Vit B12 Complex Capsules
3 pills, three times a day, after meal
Placebo ComparatorOther
Also called Placebo
Placebo that is same as gastropyloric complex capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo Comparator |
| Gastropyloric Complex Capsules | Active comparator | Not described Receives: Drug: Gastropylor Complex Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate confirmed by histology
All patients are required to repeat the histology examination after 180 days follow-up is completed.
Measured: within 180 days after treatment
Secondary outcomes (1)
clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching
Measured: within 180 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Atrophic Gastritis (CAG)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 851 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinjiang Biochemical Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kaichun WU, Professor, Principal investigator, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474044
- Sponsor's protocol ID
- CATS-CO-002
- Status last verified
- Jul 2013
- First submitted
- 27 Oct 2011
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study to Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis
- ClinicalTrials.gov ID
- NCT01474044
- Acronym / sponsor ID
- CATS-CO-002
- Conditions
- Chronic Atrophic Gastritis (CAG)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 851 participants (actual)
- Lead sponsor
- Xinjiang Biochemical Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Nov 2011 (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 study is to determine whether Gastropyloric Complex Capsules are safe and effective in the treatment of chronic atrophic gastritis (CAG).
Detailed description
Till now, there is no ideal treatment to chronic atrophic gastritis(CAG). This study is try to find a possible treatment to CAG with Gastropyloric Complex Capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo Comparator |
| Gastropyloric Complex Capsules | Active comparator | Drug: Gastropylor Complex Capsules |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 years, male or female
- Histologically diagnosed CAG
- HP negative confirmed by gastric mucosal staining
- Signed an written informed consent
Key exclusion criteria (14 listed)
- CAG with high-grade intraepithelial neoplasia
- Severe gastric mucosal erosion or bleeding needing treatment
- Active peptic ulcer, GERD, or esophageal stricture
- History of upper GI tract surgery
- History of malignant diseases
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 |
|---|---|---|
| Gastropylor Complex CapsulesAlso: Gastropyloric Extracts and Vit B12 Complex Capsules3 pills, three times a day, after meal | Drug | Gastropyloric Complex Capsules |
| Placebo ComparatorAlso: PlaceboPlacebo that is same as gastropyloric complex capsules | Other | Placebo |
Primary outcome
Effective rate confirmed by histology
Time frame: within 180 days after treatment
All patients are required to repeat the histology examination after 180 days follow-up is completed.
1 secondary outcome
clinical manifestations including abdominal pain, anorexia, nausea, vomiting, and belching
Time frame: within 180 days after treatment
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 9 Jul 2013.
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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.
Kaichun WU, Professor principal investigator
Xijing Hospital of Digestive Diseases
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 Gastropylor Complex Capsules in people with Chronic Atrophic Gastritis (CAG), run by Xinjiang Biochemical Pharmaceutical Co., Ltd. at 1 site in China.
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 14 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 9 Jul 2013. 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 China. 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 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?
Effective rate confirmed by histology (time frame: within 180 days after treatment). 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 9 Jul 2013.