Trial · NCT00669955

Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy

NCT00669955, Phase 3, Completed, Forest Laboratories; results first posted 2010-08-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy. Trials, record NCT00669955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00669955

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
NCT number: NCT00669955
Status: Completed
Phases: Phase 3
Enrollment: 440 participants, actual
Lead sponsor: Forest Laboratories
Conditions: Helicobacter Infections
Interventions: Omeprazole, amoxicillin, clarithromycin, Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
First posted: 2008-05-01
Last updated: 2017-03-16
Results first posted: 2010-08-05

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Helicobacter Pylori Eradication Confirmed by Urea Breath Test	Week 6 and week 10 follow-up visits	H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.
Secondary	Number of Patients Experiencing Treatment Emergent Adverse Events.	at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.	A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation. All safety analysis based on the safety population.
Secondary	H. Pylori Eradication and Presence or Past History of Peptic Ulcers	Week 6 and week 10 follow-up visits	Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population. Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows.
Secondary	Clarithromycin Resistance	Measured at baseline	Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline. Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above
Secondary	Metronidazole Resistance	Measured at baseline	Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline. Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml
Secondary	Overall Compliance to Study Medications	At the end of the treatment phase (days 8-14)	Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population
Secondary	Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level	Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only	Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter)

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Helicobacter Pylori Eradication Confirmed by Urea Breath Test	Week 6 and week 10 follow-up visits	No imputation method used, as this is the per protocol population, which excludes patients with missing values, or with protocol violations.	Participants	NUMBER
SECONDARY	Number of Patients Experiencing Treatment Emergent Adverse Events.	at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.	Safety population, described as all randomized patients having received at least one dose of study medication	Participants	NUMBER
SECONDARY	H. Pylori Eradication and Presence or Past History of Peptic Ulcers	Week 6 and week 10 follow-up visits	Per protocol population.	Participants	NUMBER
SECONDARY	Clarithromycin Resistance	Measured at baseline	Per protocol analysis population	participants	NUMBER
SECONDARY	Metronidazole Resistance	Measured at baseline	Per protocol population	participants	NUMBER
SECONDARY	Overall Compliance to Study Medications	At the end of the treatment phase (days 8-14)	Safety population.	participants	MEAN
SECONDARY	Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level	Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only	Plasma bismuth concentrations were analysed in the OBMT arm only. The goal was to determine whether bismuth plasma concentrations would be of 50 ug/l or above at end of treatment, or at the end of study. The results report the number of patients having reached 50 ug/l in the OBMT arm at either of these timepoints.	participants	NUMBER

Source ClinicalTrials.gov

Results by group13

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Helicobacter Pylori Eradication Confirmed by Urea Breath Test	Quadruple Therapy (OBMT) 10 Days	166	Participants
Helicobacter Pylori Eradication Confirmed by Urea Breath Test	Triple Therapy (OAC) 7 Days	112	Participants
Number of Patients Experiencing Treatment Emergent Adverse Events.	Quadruple Therapy (OBMT) 10 Days	101	Participants
Number of Patients Experiencing Treatment Emergent Adverse Events.	Triple Therapy (OAC) 7 Days	112	Participants
H. Pylori Eradication and Presence or Past History of Peptic Ulcers	Quadruple Therapy (OBMT) 10 Days	18	Participants
H. Pylori Eradication and Presence or Past History of Peptic Ulcers	Triple Therapy (OAC) 7 Days	15	Participants
Clarithromycin Resistance	Quadruple Therapy (OBMT) 10 Days	30	participants
Clarithromycin Resistance	Triple Therapy (OAC) 7 Days	2	participants
Metronidazole Resistance	Quadruple Therapy (OBMT) 10 Days	38	participants
Metronidazole Resistance	Triple Therapy (OAC) 7 Days	28	participants

1 to 10 of 13Source ClinicalTrials.gov

See all 13 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Quadruple Therapy (OBMT) 10 Days	218
Overall Study	STARTED	Triple Therapy (OAC) 7 Days	222
Overall Study	COMPLETED	Quadruple Therapy (OBMT) 10 Days	204
Overall Study	COMPLETED	Triple Therapy (OAC) 7 Days	195
Overall Study	NOT COMPLETED	Quadruple Therapy (OBMT) 10 Days	14
Overall Study	NOT COMPLETED	Triple Therapy (OAC) 7 Days	27

Source ClinicalTrials.gov

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dyspepsia	Gastrointestinal disorders	Quadruple Therapy (OBMT) 10 Days	22	216
other	Dyspepsia	Gastrointestinal disorders	Triple Therapy (OAC) 7 Days	30	222
other	Diarrhea	Gastrointestinal disorders	Quadruple Therapy (OBMT) 10 Days	14	216
other	Diarrhea	Gastrointestinal disorders	Triple Therapy (OAC) 7 Days	28	222
other	Abdominal pain upper	Vascular disorders	Quadruple Therapy (OBMT) 10 Days	18	216
other	Abdominal pain upper	Vascular disorders	Triple Therapy (OAC) 7 Days	16	222
other	Nausea	Gastrointestinal disorders	Quadruple Therapy (OBMT) 10 Days	14	216
other	Nausea	Gastrointestinal disorders	Triple Therapy (OAC) 7 Days	2	222
other	Dysgeusia	Nervous system disorders	Quadruple Therapy (OBMT) 10 Days	12	216
other	Dysgeusia	Nervous system disorders	Triple Therapy (OAC) 7 Days	22	222

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Quadruple Therapy (OBMT) 10 Days
Total, all-cause mortality	Triple Therapy (OAC) 7 Days
Total, other adverse events	Quadruple Therapy (OBMT) 10 Days	98	216
Total, other adverse events	Triple Therapy (OAC) 7 Days	105	222
Total, serious adverse events	Quadruple Therapy (OBMT) 10 Days	4	216
Total, serious adverse events	Triple Therapy (OAC) 7 Days	3	222

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21345487	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Quadruple Therapy (OBMT) 10 Days vs Triple Therapy (OAC) 7 Days: Metronidazole Resistance	Trial comparisons
Quadruple Therapy (OBMT) 10 Days vs Triple Therapy (OAC) 7 Days: H. Pylori Eradication and Presence or Past History of Peptic Ulcers	Trial comparisons
Quadruple Therapy (OBMT) 10 Days vs Triple Therapy (OAC) 7 Days: Clarithromycin Resistance	Trial comparisons
Quadruple Therapy (OBMT) 10 Days vs Triple Therapy (OAC) 7 Days: Helicobacter Pylori Eradication Confirmed by Urea Breath Test	Trial comparisons
Quadruple Therapy (OBMT) 10 Days vs Triple Therapy (OAC) 7 Days: Number of Patients Experiencing Treatment Emergent Adverse Events.	Trial comparisons
Quadruple Therapy (OBMT) 10 Days vs Triple Therapy (OAC) 7 Days: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00669955

GET https://conductscience.org/api/trials/v1/NCT00669955/events?page=2

API reference For AI assistants