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Anti-inflammatory

Sulfasalazine for Preventing Premature Birth

Q: Are there any opportunities to enroll in this trial?

Per the information on clinicaltrials.gov, this trial is presently seeking out participants. The post was initially uploaded to the website in March 1st of 2023, and has been revised as recently as 30th of that same month.

Q: What is the numerical scope of this clinical trial's enrollment?

Affirmative. Clinicaltrials.gov affirms that this trial, which was launched on March 1st 2023 and updated most recently on the 30th of March, is actively recruiting 50 eligible candidates across one centre.

Q: Has Sulfasalazine earned the endorsement of the FDA?

According to our team at Power, the safety rating of Sulfasalazine is a 2 due to it being in Phase 2 of testing. Although there is some evidence for its safety profile, efficacy remains unproven thus far.

Phase 2

Recruiting

Led By Todd Rosen, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between 35 weeks and 36 weeks 6 days of pregnancy

Awards & highlights

Study Summary

This trial aims to see if sulfasalazine can prevent preterm birth in pregnant people with a history of preterm birth by reducing CRH levels. Participants will be randomly assigned to get the drug or a control group.

Who is the study for?

This trial is for pregnant women over 18, between 12-22 weeks gestation, with a history of preterm birth and a confirmed singleton pregnancy. It's not for those under 18 or with certain medical conditions like severe asthma, liver/renal dysfunction, blood disorders, G6PD deficiency, or allergies to sulfasalazine.Check my eligibility

What is being tested?

The study tests if sulfasalazine can lower CRH levels in pregnant women who've had early births before and if it can prevent another premature birth. Participants will be randomly assigned to either receive the drug or be in a control group.See study design

What are the potential side effects?

Sulfasalazine may cause side effects such as digestive issues (nausea, vomiting), headaches, potential allergic reactions for those sensitive to the medication, and changes in blood counts which could lead to anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between 35 weeks and 36 weeks 6 days of pregnancy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between 35 weeks and 36 weeks 6 days of pregnancy

This trial's timeline: 3 weeks for screening, Varies for treatment, and between 35 weeks and 36 weeks 6 days of pregnancy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serum CRH levels

Secondary outcome measures

Composite neonatal morbidity

Digital cervical exam at 36 weeks gestational age

Medically indicated preterm birth < 37 weeks gestation

+2 more

Side effects data

From 2015 Phase 4 trial • 400 Patients • NCT01172639

33%

Upper respiratory tract infection

26%

Abdominal pain

23%

Nausea

19%

Gastroenteritis

16%

Hairloss

14%

Liver function disturbance

12%

Tendinopathy

12%

Arthralgia

Vertigo

Hypertension

Eczema

Increased transpiration

Arthrosis

Back pain

Agitation

Tooth extraction

Paresthesia

Pruritus

Anaemia

Palpitations

Venous insufficiency

Sjogren's disease

Muscle cramps

Influenza infection

Fatigue

Headache

Bronchitis

General malaise

Arthritis

Flushes

Pyrosis

Endometrioid adenocarcinoma

Rotator cuff lesion

Intervertebral disc disorder

Bladder infection

Eye infection

Insomnia

Diarrhoea

Angina

Kidney cancer malignant

Pneumonia

Cough

Genital infection

100%

80%

60%

40%

20%

Study treatment Arm

CoBRA Slim Low Risk Group

Tight Step Up Low Risk Group

CoBRA Classic High Risk Group

CoBRA Slim High Risk Group

CoBRA Avant-garde High Risk Group

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SulfasalazineExperimental Treatment1 Intervention

Pregnant persons will receive sulfasalazine daily with 500 mg/daily and increasing by 500 mg/day every week until they reach a therapeutic dose of 1,000 mg twice daily. Drug will be started at 24 weeks estimated gestational age and ended at 36 weeks or earlier if preterm birth occurs.

Group II: Standard CareActive Control1 Intervention

Pregnant persons will receive standard care in pregnancy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sulfasalazine

2016

Completed Phase 4

~1860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,182 Total Patients Enrolled

2 Trials studying Premature Birth

290 Patients Enrolled for Premature Birth

Todd Rosen, MDPrincipal InvestigatorRutgers Robert Wood Johnson Medical School

1 Previous Clinical Trials

580 Total Patients Enrolled

Media Library

Sulfasalazine (Anti-inflammatory) Clinical Trial Eligibility Overview. Trial Name: NCT05703425 — Phase 2

Premature Birth Research Study Groups: Sulfasalazine, Standard Care

Premature Birth Clinical Trial 2023: Sulfasalazine Highlights & Side Effects. Trial Name: NCT05703425 — Phase 2

Sulfasalazine (Anti-inflammatory) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05703425 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to enroll in this trial?

"Per the information on clinicaltrials.gov, this trial is presently seeking out participants. The post was initially uploaded to the website in March 1st of 2023, and has been revised as recently as 30th of that same month."

Answered by AI

What is the numerical scope of this clinical trial's enrollment?

"Affirmative. Clinicaltrials.gov affirms that this trial, which was launched on March 1st 2023 and updated most recently on the 30th of March, is actively recruiting 50 eligible candidates across one centre."

Answered by AI

Has Sulfasalazine earned the endorsement of the FDA?

"According to our team at Power, the safety rating of Sulfasalazine is a 2 due to it being in Phase 2 of testing. Although there is some evidence for its safety profile, efficacy remains unproven thus far."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of Sulfasalazine on CRH Levels in Pregnant Women

Todd Rosen, MD 2023. "The Effect of Sulfasalazine on CRH Levels in Pregnant Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05703425.