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NCT01796678 · ClinicalTrials.gov registry record · Phase 2

Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

A Phase 2 study, sponsored by UCSF Benioff Children's Hospital Oakland.

Completed
Registry status
Phase 2
Development phase
56
Enrollment target

NCT01796678: Completed Phase 2 study, sponsored by UCSF Benioff Children's Hospital Oakland.

NCT01796678 is a Phase 2 study that has completed, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 56 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01796678, a Phase 2 study, has completed, sponsored by UCSF Benioff Children's Hospital Oakland.

COMPLETED
Registry status
Phase 2
Development phase
56 participants
Enrollment target

Study Summary

Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD). Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of emergency department visits. Currently efforts to treat painful episodes with use of non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without targeting the underlying mechanisms of vaso-occlusion.Investigators have found that an arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since arginine is the obligate substrate for NO production, and an acute deficiency is associated with VOE, investigators hypothesized that arginine supplementation may be a safe and beneficial treatment for sickle cell pain.

Interventions

  • DRUG Placebo
  • DRUG Arginine

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2000-09
Est. Completion 2007-06
Phase Phase 2

What the Registry Record Tells You About NCT01796678

The ClinicalTrials.gov registry entry for NCT01796678 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCSF Benioff Children's Hospital Oakland, which has 52 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01796678 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01796678 about?

NCT01796678 is a clinical study titled "Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial". Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD). Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of emergency department visits. Currently efforts to treat painful episodes with use of non-steroidal pain relievers and intrave...

What is the current status of trial NCT01796678?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2000-09. Estimated completion is 2007-06.

What interventions are being tested in trial NCT01796678?

The interventions under investigation include: Placebo (DRUG), Arginine (DRUG).

Who is sponsoring clinical trial NCT01796678?

This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.