Trial · NCT00094887

Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises

NCT00094887, Phase 2, Completed, Mallinckrodt; results first posted 2010-04-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises. Trials, record NCT00094887. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00094887

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Trial

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

Title: Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises
NCT number: NCT00094887
Status: Completed
Phases: Phase 2
Enrollment: 150 participants, actual
Lead sponsor: Mallinckrodt
Conditions: Anemia, Sickle Cell
Interventions: Nitric Oxide, Placebo
First posted: 2004-10-28
Last updated: 2020-02-05
Results first posted: 2010-04-23

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Time to Vaso-occlusive Pain Crisis (VOC) Resolution	within 30 days	VOC resolution was defined by all of the following conditions: * Pain relief - Visual Analog Scale (VAS) pain scores of 6 or less, (6 as worst and 0 as best) * Freedom from parenteral narcotic use, * Ability to walk unless the subject was not able to walk for any reason other than acute VOC prior to the onset of crisis, * Subject and/or family's belief that the painful crisis could be managed at home with or without oral analgesic use, and the physician concurred with that assessment.
Secondary	Length of Hospitalization	within 40 days	Length of hospitalization is defined as the length of time from admission to discharge order
Secondary	Number of Participants Discharged to Home Within the First 24 Hours	within 24 hours
Secondary	Total Dose of Opioids Received	within 8 hours and within 40 days	The total dose (mg) of opioid medications received during the trial
Secondary	Number of Participants With Acute Chest Syndrome/Pneumonia Requiring Blood Transfusion	within 40 days	Number of participants who required a blood transfusion before discharge because of acute chest syndrome/pneumonia
Secondary	Number of Participants Readmitted to Hospital Within 30 Days After Discharge	during first 24 hours and during 30 day follow-up	The number of participants readmitted to the hospital for any reason within 30 days after discharge

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Vaso-occlusive Pain Crisis (VOC) Resolution	within 30 days	Primary efficacy analysis set, defined as intent to treat population with VOC resolution	Hours	MEDIAN
SECONDARY	Length of Hospitalization	within 40 days	Intention to treat	Days	MEDIAN
SECONDARY	Number of Participants Discharged to Home Within the First 24 Hours	within 24 hours	Intention to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Total Dose of Opioids Received	within 8 hours and within 40 days	Intention to treat	mg	MEDIAN
SECONDARY	Number of Participants With Acute Chest Syndrome/Pneumonia Requiring Blood Transfusion	within 40 days	Intention to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Readmitted to Hospital Within 30 Days After Discharge	during first 24 hours and during 30 day follow-up	Intention to treat	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Category	Value	Spread	Units
Time to Vaso-occlusive Pain Crisis (VOC) Resolution	Inhaled Nitric Oxide		61.83	Full Range 9.93 to 412.17	Hours
Time to Vaso-occlusive Pain Crisis (VOC) Resolution	Placebo		55.16	Full Range 8.00 to 233.00	Hours
Length of Hospitalization	Inhaled Nitric Oxide		4.06	Full Range 0.76 to 21.35	Days
Length of Hospitalization	Placebo		3.11	Full Range 0.05 to 39.02	Days
Number of Participants Discharged to Home Within the First 24 Hours	Inhaled Nitric Oxide		5		Participants
Number of Participants Discharged to Home Within the First 24 Hours	Placebo		7		Participants
Total Dose of Opioids Received	Inhaled Nitric Oxide	within 8 hours	16.25	Full Range 0.00 to 196.50	mg
Total Dose of Opioids Received	Placebo	within 8 hours	17.25	Full Range 0.00 to 440.00	mg
Total Dose of Opioids Received	Inhaled Nitric Oxide	within 40 days	153.75	Full Range 1.60 to 3117.80	mg
Total Dose of Opioids Received	Placebo	within 40 days	211.37	Full Range 2.00 to 7506.2	mg

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow14

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Inhaled Nitric Oxide	75
Overall Study	STARTED	Placebo	75
Overall Study	Safety Population	Inhaled Nitric Oxide	75
Overall Study	Safety Population	Placebo	75
Overall Study	Intent to Treat Population	Inhaled Nitric Oxide	75
Overall Study	Intent to Treat Population	Placebo	75
Overall Study	Per Protocol Analysis Set	Inhaled Nitric Oxide	71
Overall Study	Per Protocol Analysis Set	Placebo	71
Overall Study	Primary Efficacy Population	Inhaled Nitric Oxide	65
Overall Study	Primary Efficacy Population	Placebo	64

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events24

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	Anaemia	Blood and lymphatic system disorders	Inhaled Nitric Oxide	5	75	5
other	Anaemia	Blood and lymphatic system disorders	Placebo	4	75	4
other	Constipation	Gastrointestinal disorders	Inhaled Nitric Oxide	2	75	2
other	Constipation	Gastrointestinal disorders	Placebo	4	75	4
other	Headache	Nervous system disorders	Inhaled Nitric Oxide	3	75	3
other	Headache	Nervous system disorders	Placebo	5	75	5
other	Nausea	Gastrointestinal disorders	Inhaled Nitric Oxide	5	75	5
other	Nausea	Gastrointestinal disorders	Placebo	4	75	4
other	Pruritis	Skin and subcutaneous tissue disorders	Inhaled Nitric Oxide	4	75	4
other	Pruritis	Skin and subcutaneous tissue disorders	Placebo	6	75	6

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Inhaled Nitric Oxide
Total, all-cause mortality	Placebo
Total, other adverse events	Inhaled Nitric Oxide	35	75
Total, other adverse events	Placebo	33	75
Total, serious adverse events	Inhaled Nitric Oxide	7	75
Total, serious adverse events	Placebo	6	75

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1302470	BACKGROUND	PubMed
21364138	DERIVED	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 comparisons3

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

Comparison	Source
Inhaled Nitric Oxide vs Placebo: Number of Participants With Acute Chest Syndrome/Pneumonia Requiring Blood Transfusion	Trial comparisons
Inhaled Nitric Oxide vs Placebo: Number of Participants Discharged to Home Within the First 24 Hours	Trial comparisons
Inhaled Nitric Oxide 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.

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/NCT00094887

GET https://conductscience.org/api/trials/v1/NCT00094887/events?page=2

API reference For AI assistants