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Trial · NCT01265550

Registered outcomes54

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

ListOutcomeTime frameDescription
PrimaryNumber of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months12 months
Success; ≥50% improvement in the baseline GERD-HRQL score at 12 months. Failure; \<50% improvement in the baseline GERD-HRQL score at 12 months or: 1. For patients randomized to Surgical Treatment: a.\<50% improvement in the baseline GERD-HRQL score and/or persistent heartburn of sufficient severity to warrant treatment with any antisecretory medication, antireflux medication or neurotropic medication at any quarterly clinic visit. 2. For patients randomized to Active Medical or Placebo Medical Treatment: a.inability to tolerate both study medications or b.For patients treated with desipramine, i.\<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with the second drug at any quarterly clinic visit. c.For patients in whom desipramine is contraindicated,i.\<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with baclofen or its corresponding placebo at any quarterly clinic visit.
SecondaryNumber of Enrolled Participants With Esophageal Ulceration.Screening
SecondaryNumber of Enrolled Participants With Reflux Esophagus.Screening
SecondaryNumber of Enrolled Participants With Eosinophilic EsophagitisScreening
SecondaryNumber of Enrolled Participants With Active Ulceration of the Stomach and/or Duodenum.Screening
SecondaryNumber of Enrolled Participants With Neoplasm of the Esophagus, Stomach or DuodenumScreening
SecondaryNumber of Enrolled Participants With Candida Esophagitis.Screening
SecondaryNumber of Enrolled Participants With Gastric Outlet ObstructionScreening
SecondaryNumber of Enrolled Participants With AchalasiaScreening
SecondaryNumber of Enrolled Participants With AperistalsisScreening
SecondaryNumber of Enrolled Participants With Distal Esophageal SpasmScreening
SecondaryNumber of Enrolled Participants With Nutcracker EsophagusScreening
SecondaryNumber of Enrolled Participants With Ineffective Esophageal MotilityScreening
SecondaryNumber of Enrolled Participants With Rapid ContractionScreening
SecondaryNumber of Enrolled Participants With Hypertensive PeristalsisScreening
SecondaryNumber of Enrolled Participants With Jackhammer EsophagusScreening
SecondaryNumber of Enrolled Participants With Weak Peristalsis IScreening
SecondaryNumber of Enrolled Participants With Weak Peristalsis IIScreening
SecondaryNumber of Enrolled Participants With Anxiety and/or DepressionScreening
SecondaryNumber of Enrolled Participants With Functional HeartburnScreening

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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