- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03193450
Telephone-Based Re-education for Hp Eradication
Telephone-Based Re-Education of Drug Administration for Helicobacter Pylori Eradication: a Multi-Center Randomized, Controlled Study
It was suggested that the patient compliance plans an important role in the Hp eradication. However, data on whether re-education could improve the eradication rate are lacking. We consider that re-education on patients by telephone during the process of drug administration could increase the eradication rate in Hp infected patients.
We hypothesized that telephone re-education during the whole process of drug administration would improve the compliance of patients and ultimately increase the Hp eradication rate.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710061
- First Affiliated Hospital of Xi'an JiaoTong University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Prior informed consent
- 18-70 years of age
- Hp infected patients diagnosed by 13C urea breath test, including digestive ulcer, gastritis with dyspepsia symptoms, family history of gastric cancer, planning to use long-term non-steroidal anti-inflammatory drugs (NSAIDs), or personal request
- Ability to swallow oral medications
- No contraindication for the drugs used for Hp eradication
- Both men and women enrolled in this trial must use adequate barrier birth control during the course of the trial and 4 weeks after the completion of trial
Exclusion Criteria:
- Pregnant or breast-feeding subjects
- Previous failed treatment of Hp eradication
- Previous treatment with bismuth salts or antibiotics within 1 month before study enrollment, and treatment with proton pump inhibitor or H2 receptor antagonist within 2 weeks before study enrollment
- Any disease that could jeopardize the safety of subject and their compliance in the study (e.g. serious liver disease, heart disease, kidney disease, malignant tumor or alcoholism, etc.)
- Previous upper gastrointestinal surgery
- Inability to express complaint (e.g. mental disorder, psychoneurosis, unable to cooperation, etc.)
- Active clinically serious infections, except for Hepatitis B virus and hepatitis C virus infection
- Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Re-education group
Patients in this arm will receive a repeated instruction by telephone in terms of both calling and message at the forth, seventh, tenth day after the start of treatment.
|
Patients will receive a repeated instruction by telephone in terms of both calling and message at the forth, seventh, tenth day after the start of treatment.
Patients will receive an instruction card about the drug administration at the clinic by doctors.
|
Aktiv komparator: Non re-education group
Patients in this arm only received an instruction card about the drug administration at the clinic by doctors but no re-education by telephone during treatment
|
Patients will receive an instruction card about the drug administration at the clinic by doctors.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Hp eradication rate
Tidsram: 4-6 weeks after the end of drug administration
|
Eradication rate is the proportion of patients with eradicated-Hp.
Hp infection was considered eradicated when negative results were obtained by 13carbon urea breath test at 4-6 weeks after the end of drug administration
|
4-6 weeks after the end of drug administration
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Symptoms relief rate
Tidsram: 4-6 weeks after the end of drug administration
|
The symptoms were recorded according to Gastrointestinal Symptom Rating Scale.
|
4-6 weeks after the end of drug administration
|
Adverse events
Tidsram: 4-6 weeks after the end of drug administration
|
The terms and grade of adverse events will be presented according to the Common Terminology Criteria for Adverse Events (CTCAE: version 4.0)
|
4-6 weeks after the end of drug administration
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Shuixiang He, MD, PhD, First Affiliated Hospital Xi'an Jiaotong University
Publikationer och användbara länkar
Allmänna publikationer
- Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.
- McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010 Apr 29;362(17):1597-604. doi: 10.1056/NEJMcp1001110. No abstract available.
- Malfertheiner P, Sipponen P, Naumann M, Moayyedi P, Megraud F, Xiao SD, Sugano K, Nyren O; Lejondal H. pylori-Gastric Cancer Task Force. Helicobacter pylori eradication has the potential to prevent gastric cancer: a state-of-the-art critique. Am J Gastroenterol. 2005 Sep;100(9):2100-15. doi: 10.1111/j.1572-0241.2005.41688.x.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- XAJTU-DG001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Helicobacter pylori-infektion
-
Institut PasteurRekrytering
-
ImevaXAvslutadHelicobacter Pylori-infekterade försökspersoner | Helicobacter Pylori Naiva ämnenTyskland
-
Fu Jen Catholic University HospitalAktiv, inte rekryterandeHelicobacter pyloriTaiwan
-
Poitiers University HospitalAvslutad
-
Shandong UniversityOkändHelicobacter pyloriKina
-
TakedaAvslutad
-
Hamamatsu UniversityOita UniversityOkändHelicobacter pyloriJapan
-
National Liver Institute, EgyptFuture pharmaceutical industriesRekryteringHelicobacter pyloriEgypten
-
Hillel Yaffe Medical CenterHar inte rekryterat ännu
Kliniska prövningar på telephone-based re-education
-
Wake Forest University Health SciencesPatient-Centered Outcomes Research Institute; Atrium Health Levine Cancer...AvslutadSicklecellanemiFörenta staterna
-
Ayşe ARIKAN DÖNMEZHar inte rekryterat ännuDemens | Virtuell verklighet | Utbildning | SjuksköterskestudenterKalkon
-
Uskudar UniversityAvslutadSmärta | Fibromyalgi | Psykologisk regressionKalkon
-
Scripps Whittier Diabetes InstituteRekryteringDiabetes typ 2Förenta staterna
-
Universidad Francisco de VitoriaAvslutadStress, psykologiskSpanien