Gastroesophageal Reflux DiseasePhase 1NCT00414856
Effects of AFQ056 and Baclofen on Meal-Induced Gastroesophageal Reflux
A Phase 1 study testing AFQ056 in people with Gastroesophageal Reflux Disease, run by Novartis at 4 sites in 4 countries.
Trial summary
This study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- AFQ056
- How many people
- 34 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2006to not given
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients with GERD (18-60 years) with a history of moderate to severe reflux symptoms (heartburn or acid regurgitation more than 2 days/week, and/or night-time reflux, and/or after meal reflux) for ≥ 3 months with:
- uncomplicated reflux-esophagitis of any degree as evidenced by esophagogastroduodenoscopy (EGD) within the last 12 months, OR (and) a pathological ambulatory 24-hours pH measurement within the last 12 months with pH < 4 for ≥ 9% of the time.
- Females must be of no child bearing potential (postmenopausal women with no regular menstrual bleeding for at least 1 year or women who have been surgically sterilized at least 6 months prior). Menopause will be confirmed by a plasma FSH level of 37.0 - 185.0 mIU/mL. Surgical sterilization procedures must be supported with clinical documentation.
- Patients must be able to completely finish the high-fat breakfast within 15 minutes.
- Body mass index must be below 30. Patients must weigh at least 60 kg to participate in this study.
- Patients must be able to communicate well with the investigator, to understand and comply with the requirements of the study and to understand and sign the written informed consent.
Who cannot join
- History of:
- Upper gastrointestinal (GI) surgery or radiation
- GI disorders other than GERD that may significantly affect the incidence and/or assessment of reflux episodes (GI motility disorders, connective tissue disease like scleroderma, Barrett's esophagus, hiatal hernia > 3-4 cm, previous esophageal bleeding, esophageal varices, active gastric or duodenal ulcer disease, active esophagitis
- Delayed gastric emptying, or endoscopic indications for a delay in gastric emptying or gastric outlet obstruction.
- Neurologic/psychiatric disorders including a family history of epilepsy clinically significant cardiac disease
- Diabetes mellitus or other metabolic disorders including hyperlipidemia requiring treatment
Show all 17Show fewer
- Any significant acute or chronic conditions except for following treated by the quoted drugs with a stable therapy for at least 4 weeks:
- Hypertension well-controlled with the following:
- ACE inhibitors: benazepril, captopril, cilazapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril tert-butylamine, quinapril, ramipril, spirapril, trandolapril, zofenopril, and/or
- angiotensin II receptor antagonists: candesartan cilexetil, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, and/or
- diuretics: amiloride, bendroflumethiazide, bumetanide, canrenoate de potassium, chlortalidone, cicletanine, clopamide, cyclothiazide, furosemide, hydrochlorothiazide, indapamide, methyclothiazide, piretanide, spironolactone, torasemide, triamterene, xipamide, and/or
- calcium antagonists: bepridil, felodipine, isradipine, lercanidipine, manidipine, nimodipine, nitrendipine, amlodipine, nicardipine BUT NOT diltiazem, nifedipine, verapamil
- Well-compensated asthma with topical use of corticosteroids and/or β2-mimetics
- Patients on thyroid hormone therapy with a normal TSH value.
- Nonsteroidal anti-inflammatory drugs including aspirin use in the week prior to treatment/impedance monitoring.
- Patients with body mass index ≥ 30.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo- and Positive-Control, Double-Dummy, 3 Parallel Cohort, Two-Way Crossover Single Oral Dose Study in GERD (Gastro Esophageal Reflux Disease) Patients to Evaluate the Effects of AFQ056 and Baclofen (Positive Control) on the Incidence of Meal-Induced Gastro Esophageal Reflux Events
This study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- AFQ056
- Keywords
- GERD, gastroesophageal reflux disease, meal-induced gastroesophageal reflux events
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFQ056Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroesophageal reflux episodes as assessed by impedance measurements in the 4-hour period following a standardized high-fat meal in patients with GERD.
Secondary outcomes (5)
Safety and tolerability of oral AFQ056 in GERD patients.
Pharmacokinetics (PK) of two AFQ056 single oral doses in patients with GERD.
Relationships between AFQ056 blood levels and/or how the body interacts with the medication and overall reflux incidence
Validation of the reflux model used in this study using baclofen as positive control.
Effects of AFQ056 on other impedance/pH parameters, including but not limited to the rate of reflux episodes at various time intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414856
- Sponsor's protocol ID
- CAFQ056A2108
- Status last verified
- Jun 2007
- First submitted
- 21 Dec 2006
- Last updated
- 22 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo- and Positive-Control, Double-Dummy, 3 Parallel Cohort, Two-Way Crossover Single Oral Dose Study in GERD (Gastro Esophageal Reflux Disease) Patients to Evaluate the Effects of AFQ056 and Baclofen (Positive Control) on the Incidence of Meal-Induced Gastro Esophageal Reflux Events
- ClinicalTrials.gov ID
- NCT00414856
- Acronym / sponsor ID
- CAFQ056A2108
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, gastroesophageal reflux disease, meal-induced gastroesophageal reflux events
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- First posted
- 22 Dec 2006 (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.
This study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female patients with GERD (18-60 years) with a history of moderate to severe reflux symptoms (heartburn or acid regurgitation more than 2 days/week, and/or night-time reflux, and/or after meal reflux) for ≥ 3 months with:
- Females must be of no child bearing potential (postmenopausal women with no regular menstrual bleeding for at least 1 year or women who have been surgically sterilized at least 6 months prior). Menopause will be confirmed by a plasma FSH level of 37.0 - 185.0 mIU/mL. Surgical sterilization procedures must be supported with clinical documentation.
- Patients must be able to completely finish the high-fat breakfast within 15 minutes.
- Body mass index must be below 30. Patients must weigh at least 60 kg to participate in this study.
- Patients must be able to communicate well with the investigator, to understand and comply with the requirements of the study and to understand and sign the written informed consent.
Key exclusion criteria (17 listed)
- Upper gastrointestinal (GI) surgery or radiation
- GI disorders other than GERD that may significantly affect the incidence and/or assessment of reflux episodes (GI motility disorders, connective tissue disease like scleroderma, Barrett's esophagus, hiatal hernia > 3-4 cm, previous esophageal bleeding, esophageal varices, active gastric or duodenal ulcer disease, active esophagitis
- Delayed gastric emptying, or endoscopic indications for a delay in gastric emptying or gastric outlet obstruction.
- Neurologic/psychiatric disorders including a family history of epilepsy clinically significant cardiac disease
- Diabetes mellitus or other metabolic disorders including hyperlipidemia requiring 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 |
|---|---|---|
| AFQ056 | Drug | – |
Primary outcome
Gastroesophageal reflux episodes as assessed by impedance measurements in the 4-hour period following a standardized high-fat meal in patients with GERD.
5 secondary outcomes
Safety and tolerability of oral AFQ056 in GERD patients.
Pharmacokinetics (PK) of two AFQ056 single oral doses in patients with GERD.
Relationships between AFQ056 blood levels and/or how the body interacts with the medication and overall reflux incidence
Validation of the reflux model used in this study using baclofen as positive control.
Effects of AFQ056 on other impedance/pH parameters, including but not limited to the rate of reflux episodes at various time intervals
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 22 Jun 2007.
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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.
Novartis principal investigator
Investigator site
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFQ056 in people with Gastroesophageal Reflux Disease, run by Novartis at 4 sites in 4 countries.
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 6 inclusion and 17 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 22 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France, Germany, Switzerland. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Gastroesophageal reflux episodes as assessed by impedance measurements in the 4-hour period following a standardized high-fat meal in patients with GERD.. 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 22 Jun 2007.