Trial · NCT04839354
Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial
NCT04839354, Phase 3, Completed, Claudia R. Morris; results first posted 2025-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial. Trials, record NCT04839354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04839354
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial
- NCT number
- NCT04839354
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 271 participants, actual
- Lead sponsor
- Claudia R. Morris
- Conditions
- Sickle Cell Disease
- Interventions
- L-Arginine Hydrochloride, Normal saline
- First posted
- 2021-04-09
- Last updated
- 2026-06-23
- Results first posted
- 2025-07-30
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-to-crisis Resolution | From study drug delivery to last IV opioid treatment (up to 1,724.1 hours) | The time-to-crisis resolution is defined as the time in hours from the date and time of the first study drug delivery to time of the last dose of parenteral opioid delivery. |
| Secondary | Total Parenteral Opioid Use | From the time of IV placement throughout opioid treatment (up to 1,724.1 hours) | Total parenteral opioid use is assessed as morphine equivalents in milligrams per kilogram (mg/kg). |
| Secondary | Change in Pain Score | Time of presentation and on the day of discharge (up to 554.8 days) | Pain is assessed using a scale from 0 to 10, where 10 is the highest pain level. Daily highest and lowest pain scores are recorded. The change in score is calculated by subtracting the score at discharge from the score at the time of presentation. |
| Secondary | Change in Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Score | Within 12 hours of study drug delivery, and on the day of discharge (up to 554.8 days) | The PROMIS Pain Interference instrument is an 8-item, self-administered survey that assesses the interference of pain on daily activities. Participants are asked to respond to questions regarding the extent of their pain. Responses range from 1 to 5, where 1 represents "not at all" and 5 represents "very much". Total raw scores are converted to T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Scores below 50 indicate a lower amount of pain interference compared to the reference population, while scores higher than 50 indicate greater pain interference compared to the reference population. The change in score is calculated by subtracting the score at the time of discharge from the score from within 12 hours of study drug delivery. The change in score is calculated by subtracting the score at discharge from the score within 12 hours of study drug delivery. |
| Secondary | Change in PROMIS Pain Behavior Score | Within 12 hours of study drug delivery, and on the day of discharge (up to 554.8 days) | The PROMIS Pain Behavior instrument is an 8-item, self-administered survey that assesses external manifestations of pain. Participants are asked to respond to questions regarding the extent of their pain. Responses range from 1 to 5, where 1 represents "never" and 5 represents "always". Total raw scores are converted to T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Scores below 50 indicate a lower amount of pain behavior compared to the reference population, while scores higher than 50 indicate greater pain behavior compared to the reference population. The change in score is calculated by subtracting the score at discharge from the score within 12 hours of study drug delivery. |
| Secondary | Change in PROMIS Fatigue Score | Within 12 hours of study drug delivery and on the day of discharge (up to 554.8 days) | The PROMIS Fatigue instrument is an 8-item, self-administered survey that assesses fatigue level within the past seven days. Participants are asked to respond to questions regarding fatigue frequency. Responses range from 1 to 5, where 1 represents "never" and five represents "always". Total raw scores are converted to T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Scores below 50 indicate a lower amount of fatigue compared to the reference population, while scores higher than 50 indicate greater fatigue compared to the reference population. The change in score is calculated by subtracting the score at discharge from the score within 12 hours of study drug delivery. |
| Other | Time-to-crisis Resolution By Sex | From study drug delivery to last IV opioid treatment (up to 1,724.1 hours) | The time-to-crisis resolution is defined as the time in hours from the date and time of the first study drug delivery to time of the last dose of parenteral opioid delivery. |
| Other | Time-to-crisis Resolution By Race | From study drug delivery to last IV opioid treatment (up to 1,724.1 hours) | The time-to-crisis resolution is defined as the time in hours from the date and time of the first study drug delivery to time of the last dose of parenteral opioid delivery. |
| Other | Time-to-crisis Resolution By Ethnicity | From study drug delivery to last IV opioid treatment (up to 1,724.1 hours) | The time-to-crisis resolution is defined as the time in hours from the date and time of the first study drug delivery to time of the last dose of parenteral opioid delivery. |
| Other | Medication Quantification Score (MQS) | Pre-dose and on day of discharge (up to 2 months) | Medication Quantification Score (MQS) is a tool to objectively quantify pain. The MQS is a validated score calculated based off of daily doses of pain related medications (including acetaminophen, aspirin, NSAIDs, and antidepressants). The MQS is a single numeric value for a patient's pain medication profile. This number is used to track pain levels through a treatment course. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time-to-crisis Resolution | From study drug delivery to last IV opioid treatment (up to 1,724.1 hours) | hours | MEAN | |
| SECONDARY | Total Parenteral Opioid Use | From the time of IV placement throughout opioid treatment (up to 1,724.1 hours) | milligrams per kilogram (mg/kg) | MEAN | |
| SECONDARY | Change in Pain Score | Time of presentation and on the day of discharge (up to 554.8 days) | score on a scale | MEAN | |
| SECONDARY | Change in Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Score | Within 12 hours of study drug delivery, and on the day of discharge (up to 554.8 days) | score on a scale | MEAN | |
| SECONDARY | Change in PROMIS Pain Behavior Score | Within 12 hours of study drug delivery, and on the day of discharge (up to 554.8 days) | score on a scale | MEAN | |
| SECONDARY | Change in PROMIS Fatigue Score | Within 12 hours of study drug delivery and on the day of discharge (up to 554.8 days) | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Medication Quantification Score (MQS) | Pre-dose and on day of discharge (up to 2 months) | |||
| OTHER_PRE_SPECIFIED | Hospital Length of Stay | Up to 6 months | |||
| OTHER_PRE_SPECIFIED | Pediatric PROMIS Score | Within 12 hours of study drug delivery and on the day of discharge (up to 2 months) | |||
| OTHER_PRE_SPECIFIED | PedsQL SCD Pain and Hurt Scale Score | Within 12 hours of study drug delivery and on the day of discharge (up to 2 months) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time-to-crisis Resolution | L-Arginine Hydrochloride | 81.5 | Standard Deviation 79.6 | hours | |
| Time-to-crisis Resolution | Placebo | 88.6 | Standard Deviation 152.2 | hours | |
| Total Parenteral Opioid Use | L-Arginine Hydrochloride | 2.6 | Standard Deviation 4.5 | milligrams per kilogram (mg/kg) | |
| Total Parenteral Opioid Use | Placebo | 1.9 | Standard Deviation 2.8 | milligrams per kilogram (mg/kg) | |
| Change in Pain Score | L-Arginine Hydrochloride | 3.5 | Standard Deviation 3.3 | score on a scale | |
| Change in Pain Score | Placebo | 3.7 | Standard Deviation 3.3 | score on a scale | |
| Change in Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Score | L-Arginine Hydrochloride | 3.5 | Standard Deviation 3.3 | score on a scale | |
| Change in Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Score | Placebo | 3.7 | Standard Deviation 3.3 | score on a scale | |
| Change in PROMIS Pain Behavior Score | L-Arginine Hydrochloride | 0.8 | Standard Deviation 6.8 | score on a scale | |
| Change in PROMIS Pain Behavior Score | Placebo | 1.0 | Standard Deviation 7.1 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | L-Arginine Hydrochloride | 129 | |
| Overall Study | STARTED | Placebo | 142 | |
| Overall Study | COMPLETED | L-Arginine Hydrochloride | 129 | |
| Overall Study | COMPLETED | Placebo | 142 | |
| Overall Study | NOT COMPLETED | L-Arginine Hydrochloride | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events50
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 | Events |
|---|---|---|---|---|---|---|
| other | Abdomial pain | General disorders | L-Arginine Hydrochloride | 10 | 129 | |
| other | Abdomial pain | General disorders | Placebo | 5 | 142 | |
| other | Acute chest syndrome | Respiratory, thoracic and mediastinal disorders | L-Arginine Hydrochloride | 9 | 129 | |
| other | Acute chest syndrome | Respiratory, thoracic and mediastinal disorders | Placebo | 10 | 142 | |
| other | Decreased appetite | General disorders | L-Arginine Hydrochloride | 10 | 129 | |
| other | Decreased appetite | General disorders | Placebo | 5 | 142 | |
| other | Decreased haemoglobin | Blood and lymphatic system disorders | L-Arginine Hydrochloride | 12 | 129 | |
| other | Decreased haemoglobin | Blood and lymphatic system disorders | Placebo | 5 | 142 | |
| other | Headache | General disorders | L-Arginine Hydrochloride | 15 | 129 | |
| other | Headache | General disorders | Placebo | 14 | 142 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | L-Arginine Hydrochloride | 0 | 129 |
| Total, all-cause mortality | Placebo | 0 | 142 |
| Total, other adverse events | L-Arginine Hydrochloride | 81 | 129 |
| Total, other adverse events | Placebo | 83 | 142 |
| Total, serious adverse events | L-Arginine Hydrochloride | 22 | 129 |
| Total, serious adverse events | Placebo | 25 | 142 |
Source ClinicalTrials.gov
Papers14
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UG3HL148560 | 1/2 Sickel Cell Disease Treatment with Arginine Therapy (STArT Trial) | MORRIS, CLAUDIA R | EMORY UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2020 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| L-Arginine Hydrochloride vs Placebo: deaths from any cause | Trial comparisons |
| L-Arginine Hydrochloride vs Placebo: 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.
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/NCT04839354
GET https://conductscience.org/api/trials/v1/NCT04839354/events?page=2