Using Celecoxib to Prevent Progression in Peutz-Jeghers Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Celecoxib, a nonsteroidal anti-inflammatory drug, to prevent the progression of Peutz-Jeghers Syndrome (PJS) in patients aged 8 years and older. PJS is characterized by the development of multiple gastrointestinal polyps and an increased risk of malignancies, leading to frequent surgical interventions. The trial aims to assess whether Celecoxib can reduce the number and size of small bowel polyps, potentially decreasing the need for surgical treatments. Participants will be randomly assigned to receive either Celecoxib or a placebo to evaluate the drug's effectiveness in managing this rare condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\- Patients with PJS ≥ 8 years of age

Diagnostic criteria for PJS: meeting any of the following criteria or presence of an STK11 gene variant:

1. Two or more histologically confirmed PJS hamartomatous polyps;
2. Any number of PJS polyps detected in an individual with a family history of PJS in close relative(s);
3. Characteristic mucocutaneous pigmentation in an individual with a family history of PJS in close relative(s);
4. Any number of PJS polyps in an individual with characteristic mucocutaneous pigmentation.

Exclusion Criteria:

1. Allergy to NSAIDs;
2. Long-term use of any dose of NSAIDs, including aspirin or celecoxib, within 6 months prior to enrollment (willing to undergo a 3-month washout period to restore eligibility);
3. Imaging indicate small intestinal polyps ≥ 3 cm in diameter, intestinal intussusception, intestinal obstruction or intestinal tumor at the time of enrollment;
4. Surgical treatment for small intestinal polyps within 2 years prior to enrollment;
5. Anticipated small bowel resection due to severe polyps within 6 months of enrollment;
6. Receiving other medications for gastrointestinal polyps;
7. Peptic ulcer within 3 months prior to enrollment;
8. Unstable cardiorespiratory condition;
9. Serious renal, hepatic or haematological dysfunction (creatinine \>1.5 × ULN; ALT \>1.5 × ULN, AST \>1.5 × ULN, ALP \>1.5 × ULN, TBIL \>2 × ULN; haemoglobin \<10 g/dL, platelet count \<100,000/mL, white blood cells \<3000/mL) or other systemic diseases are unsuitable for participation in this study;
10. Pregnancy or breastfeeding;
11. Unwilling or unable to sign the informed consent form

Where it's running

• Xijing Hospital of Digestive Diseases, Air Force Military Medical University
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Hui Luo Associate professor
• Email: huiluowork@163.com
• Phone: 86-29-84771536

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.