Gastroesophageal Reflux DiseasePhase 3PANDANCT01710462
Clinical Study, Multicenter, Randomized With 2 Arms of Pantoprazole + Domperidone and Pantoprazole Isolated at the Gastroesophageal Reflux Disease
A Phase 3 study testing Pantoprazole + Domperidone and Pantozol® in people with Gastroesophageal Reflux Disease, run by Eurofarma Laboratorios S.A. at 8 sites in Brazil.
Trial summary
This superiority phase III study to compare the combination of Pantoprazole and Domperidone with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The hypothesis is that combination of the two medication at the unique capsule is better to the patients because decrease the quantity of times the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Pantoprazole + Domperidone and Pantozol®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesBrazil
- Study dates
- Aug 2013to not given
- Phase
- Phase 3
- 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
- Subscription of IC;
- Age ≥ 18 years and <70 years
- Diagnosis initial clinical or previous symptomatic GERD;
- Symptom score ≥ 4;
- Ability to conduct examinations of endoscopy;
- Ability to perform washout of drug classes PPIs, H2 antagonists, and prokinetics for at least 14 days.
Who cannot join
- Presence of esophagitis requiring intervention, esophageal varices, Barrett's esophagus, scleroderma, ulcers (gastric or duodenal), atrophic gastritis, or vagotomy pangastritis detected at the time of study enrollment;
- Eradication treatment of H. pylori completed less than 15 days of V0;
- Presence of alarm symptoms (weight loss greater than 5% in the last 60 days, no evidence of gastrointestinal bleeding);
- Gastric or esophageal surgery prior (except for simple ulcer closure);
- Females in pregnancy, lactation, or who wish to become pregnant if they refuse to use adequate contraception during the study period.
- Concomitant serious diseases such as kidney failure, heart and liver;
Show all 16Show fewer
- Suspected or confirmed any cancer except carcinoma in situ or nonmelanoma skin cancer diagnosed in the last 5 years;
- History of gastric cancer in relatives of 1st degree;
- Use of illicit drugs or alcohol abuse according to the investigator;
- Values changed (outside the normal range for the local laboratory) in leukocytes, platelets or hemoglobin;
- Significant changes in serum sodium, potassium, calcium or creatinine;
- Intolerance or allergy to any component of the drugs evaluated in the study;
- Use of anti-inflammatory drugs (NSAIDs), antiemetics, macrolides and systemic steroids for a period of not less than 2 weeks prior to the study or who have expected necessity of prolonged use during the study treatment;
- Current use of bisphosphonates, as well as those who need calcium channel blockers or other drugs that affect esophageal motility or lower esophageal sphincter tone.
- Use of other scheduled medications metabolized by cytochrome CYP3A4 during the study;
- Participation recent (past 12 months) or participation in a clinical trial expected during this study in other clinical trials involving drugs of any kind.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Belo Horizonte
Belo Horizonte, Minas Gerais
Campinas
Campinas, São Paulo
Curitiba
Curitiba, Paraná
Goiania
Goiânia, Goiás
Jaú
Jaú, São Paulo
Porto Alegre
Porto Alegre, Rio Grande do Sul
Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
São José do Rio Preto
São José do Rio Preto, São Paulo
About this study
This superiority phase III study to compare the combination of Pantoprazole and Domperidone with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The hypothesis is that combination of the two medication at the unique capsule is better to the patients because decrease the quantity of times the patients need to take medicines during the day.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Pantoprazole + Domperidone, Pantozol®
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pantoprazole + DomperidoneDrug
Pantozol®Drug
| Study group | Role | What they receive |
|---|---|---|
| Pantoprazole + Domperidone | Experimental | The combination of pantoprazole and domperidone provided for the study will be the new incremental formulation produced by Eurofarma. For this study will be used doses of capsules containing 20 mg pantoprazole, 20 mg of domperidone. Receives: Drug: Pantoprazole + Domperidone |
| Pantozol® (Takeda) | Active comparator | The Pantozol® may be presented in boxes of coated tablets of 20 mg or 40 mg. For this study will be used 20 mg tablets. Receives: Drug: Pantozol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of pantoprazole + domperidone Eurofarma at the treatment of gastroesophageal reflux disease in relation to the reference drug during 56 days using the score of symptoms
The primary objective of the study is to evaluate the efficacy of combining incremental pantoprazole and domperidone Eurofarma the treatment of gastroesophageal reflux disease in relation to the reference drug. The primary endpoint is the score of symptoms (heartburn and regurgitation) including the severity and frequency after treatment
Measured: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Secondary outcomes (3)
Quality of life during the study treatment
Measured: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Endoscopic cure rate for patients with erosive gastroesophageal reflux disease
Measured: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Frequency of adverse events observed
Measured: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startAug 2013
Why it stopped: Change of company's strategy
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710462
- Sponsor's protocol ID
- EF129
- Acronym
- PANDA
- Status last verified
- Oct 2012
- First submitted
- 15 Oct 2012
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study, Multicenter, Randomized With 2 Arms of Pantoprazole + Domperidone and Pantoprazole Isolated at the Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT01710462
- Acronym / sponsor ID
- PANDA / EF129
- Conditions
- Gastroesophageal Reflux Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of company's strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- First posted
- 19 Oct 2012 (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 superiority phase III study to compare the combination of Pantoprazole and Domperidone with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The hypothesis is that combination of the two medication at the unique capsule is better to the patients because decrease the quantity of times the patients need to take medicines during the day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pantoprazole + Domperidone | Experimental | Drug: Pantoprazole + DomperidoneThe combination of pantoprazole and domperidone provided for the study will be the new incremental formulation produced by Eurofarma. For this study will be used doses of capsules containing 20 mg pantoprazole, 20 mg of domperidone. |
| Pantozol® (Takeda) | Active comparator | Drug: Pantozol®The Pantozol® may be presented in boxes of coated tablets of 20 mg or 40 mg. For this study will be used 20 mg tablets. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subscription of IC;
- Age ≥ 18 years and <70 years
- Diagnosis initial clinical or previous symptomatic GERD;
- Symptom score ≥ 4;
- Ability to conduct examinations of endoscopy;
Key exclusion criteria (16 listed)
- Presence of esophagitis requiring intervention, esophageal varices, Barrett's esophagus, scleroderma, ulcers (gastric or duodenal), atrophic gastritis, or vagotomy pangastritis detected at the time of study enrollment;
- Eradication treatment of H. pylori completed less than 15 days of V0;
- Presence of alarm symptoms (weight loss greater than 5% in the last 60 days, no evidence of gastrointestinal bleeding);
- Gastric or esophageal surgery prior (except for simple ulcer closure);
- Females in pregnancy, lactation, or who wish to become pregnant if they refuse to use adequate contraception during the study period.
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 |
|---|---|---|
| Pantoprazole + Domperidone | Drug | Pantoprazole + Domperidone |
| Pantozol® | Drug | Pantozol® (Takeda) |
Primary outcome
Evaluate the efficacy of pantoprazole + domperidone Eurofarma at the treatment of gastroesophageal reflux disease in relation to the reference drug during 56 days using the score of symptoms
Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
The primary objective of the study is to evaluate the efficacy of combining incremental pantoprazole and domperidone Eurofarma the treatment of gastroesophageal reflux disease in relation to the reference drug. The primary endpoint is the score of symptoms (heartburn and regurgitation) including the severity and frequency after treatment
3 secondary outcomes
Quality of life during the study treatment
Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Endoscopic cure rate for patients with erosive gastroesophageal reflux disease
Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Frequency of adverse events observed
Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pantoprazole + Domperidone and Pantozol® in people with Gastroesophageal Reflux Disease, run by Eurofarma Laboratorios S.A. at 8 sites in Brazil.
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 16 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: withdrawn, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Evaluate the efficacy of pantoprazole + domperidone Eurofarma at the treatment of gastroesophageal reflux disease in relation to the reference drug during 56 days using the score of symptoms (time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days). 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 24 Jul 2015.