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Nitrous Oxide

Phase 3

Complex Regional Pain Syndrome | Small molecule | Pain |Community Health Systems, Inc.|Last Updated: Feb 9, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

Nitrous Oxide · 2 trials · 2 indications

Phase 3 2
NCT03879538Nitrous Oxide for the Treatment of Complex Regional Pain SyndromeComplex Regional Pain Syndrome
COMPLETED44 Analytics
NCT00781352Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded StudyColorectal Cancer
COMPLETED408 Analytics
PHASE3COMPLETED
Nitrous Oxide for the Treatment of Complex Regional Pain Syndrome
Complex Regional Pain SyndromeUnlock trial analytics
PHASE3COMPLETED
Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Pain Score
one-week and one-month follow-up time points

scales ranging from 0 - "no pain" to 10 - "worst pain ever" based on the PROMIS-29 v2.0 questionnaire.

To determine if the risk of colorectal cancer recurrence was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during colorectal surgery.
270 days post surgery

Secondary Endpoints

PROMIS-29 Survey Physical Health Z-score, Mental Health Z-score
one-week and one-month follow-ups after treatments were ended
PGIC Scale
one-week and one-month follow-ups.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
The nitrous oxide groupACTIVE_COMPARATORNitrous oxide group will receive 50% nitrous oxide mixed with 50% oxygen, inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit.
The Control GroupPLACEBO_COMPARATORControl group will receive 50% oxygen, inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit.
group 1ACTIVE_COMPARATORColorectal surgery with 65% nitrous oxide administration
group 2ACTIVE_COMPARATORColorectal surgery with nitrogen administration

Interventions

NameTypeDescription
Nitrous OxideDRUGA total of three inhalation treatments with 50% Nitrous Oxide plus 50% oxygen (6 total exposure hours) over one week with 2 or 3 days between each session.
OxygenDRUGA total of three inhalation treatments with 50% oxygen (6 total exposure hours) over one week with 2 or 3 days between each session.
nitrogenDRUGNitrogen administration during surgery
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients must be diagnosed with CRPS based on the revised International Association for the Study of Pain criteria. 2. Duration of disease must be at least 6 months. 3. Written informed consent. Exclusion Criteria: 1. Patients who had no subjective benefit from ketamine inf...

Countries:United StatesAustria
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Frequently asked questions about Nitrous Oxide

What is Nitrous Oxide used for?

Nitrous Oxide is being studied for use in Complex Regional Pain Syndrome and Colorectal Cancer. In clinical trials, it is evaluated as a treatment for these conditions, with studies examining its effect on cancer recurrence after colorectal surgery and its potential as a therapy for Complex Regional Pain Syndrome.

Who makes Nitrous Oxide?

Nitrous Oxide is being developed by Community Health Systems, Inc., a company traded under the ticker CYH. The company is conducting clinical trials to evaluate the drug's efficacy in treating Complex Regional Pain Syndrome and Colorectal Cancer.

What phase is Nitrous Oxide in?

Nitrous Oxide is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing trials are designed to assess its safety and effectiveness in the studied indications.

What clinical trials is Nitrous Oxide in?

Nitrous Oxide has been studied in two Phase 3 trials. One trial, NCT00781352, examined its effect on cancer recurrence after colorectal surgery in 408 patients with Colorectal Cancer. Another trial, NCT03879538, evaluated its use for Complex Regional Pain Syndrome in 44 patients. Both trials are completed.

How does Nitrous Oxide work?

Nitrous Oxide is a small molecule that acts as an anesthetic and analgesic agent. Its mechanism of action involves modulating neurotransmitter systems in the central nervous system, which can produce pain-relieving effects. This mechanism is relevant to its potential use in pain-related conditions.