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Prevention study for Peutz-Jeghers Syndrome
Official title Celecoxib for Prevention of Progression in Peutz-Jeghers Syndrome
ClinicalTrials.gov ID: NCT06722534
What this study is testing
What is Celecoxib 400mg?
Celecoxib 400mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for peutz-jeghers syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The Peutz-Jeghers Syndrome (PJS) is a rare autosomal dominant syndrome characterized by mucocutaneous pigmentations, multiple gastrointestinal hamartomatous polyps, and an elevated risk of developing malignancies. Patients with PJS often experience recurrent gastrointestinal polyps that gradually increase in number and size, requiring repeated treatments.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older
You may be able to join if
- \- Patients with PJS ≥ 8 years of age Diagnostic criteria for PJS: meeting any of the following criteria or presence of an STK11 gene variant:
- Two or more histologically confirmed PJS hamartomatous polyps;
- Any number of PJS polyps detected in an individual with a family history of PJS in close relative(s);
- Characteristic mucocutaneous pigmentation in an individual with a family history of PJS in close relative(s);
- Any number of PJS polyps in an individual with characteristic mucocutaneous pigmentation.
You likely can't join if
- Allergy to NSAIDs;
- 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...
- Imaging indicate small intestinal polyps ≥ 3 cm in diameter, intestinal intussusception, intestinal obstruction or intestinal tumor at the time of...
- Surgical treatment for small intestinal polyps within 2 years prior to enrollment;
- Anticipated small bowel resection due to severe polyps within 6 months of enrollment;
- Receiving other medications for gastrointestinal polyps;
See the full eligibility 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:
- Two or more histologically confirmed PJS hamartomatous polyps;
- Any number of PJS polyps detected in an individual with a family history of PJS in close relative(s);
- Characteristic mucocutaneous pigmentation in an individual with a family history of PJS in close relative(s);
- Any number of PJS polyps in an individual with characteristic mucocutaneous pigmentation.
- Allergy to NSAIDs;
- 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);
- Imaging indicate small intestinal polyps ≥ 3 cm in diameter, intestinal intussusception, intestinal obstruction or intestinal tumor at the time of enrollment;
- Surgical treatment for small intestinal polyps within 2 years prior to enrollment;
- Anticipated small bowel resection due to severe polyps within 6 months of enrollment;
- Receiving other medications for gastrointestinal polyps;
- Peptic ulcer within 3 months prior to enrollment;
- Unstable cardiorespiratory condition;
- 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...
- Pregnancy or breastfeeding;
- Unwilling or unable to sign the informed consent form
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.