Clinical trial · Interventional
Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis
Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis
NCT00026468CI-TRIAL-00011459withdrawnPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principle Investigator has left the University.
Summary
Brief summary (as posted)
RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis. PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exisulind | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* One of the following diagnosis:
* Diagnosis of familial adenomatous polyposis
* Prior total or subtotal colectomy
* Attenuated adenomatous polyposis coli
* May have colon intact
* 10-40 duodenal polyps from second portion to 10 cm distal to papilla of Vater
PATIENT CHARACTERISTICS:
Age:
* 18 to 80
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin at least 10 g/dL
* Platelet count at least 100,000/mm\^3
* No active hematologic disease
Hepatic:
* AST and ALT less than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 1.5 times ULN
* No active hepatic disease
Renal:
* Creatinine less than 1.5 mg/dL
* No active renal disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active peptic ulcer disease
* No serious underlying medical or psychiatric illness that would preclude completion of the study or limit survival
* No prisoners or institutionalized patients
* No known allergy to sulindac or related compounds
* No active internal malignancy within the past 5 years
* No alcohol or drug abuse within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
Other:
* No prior non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates more than 10 days a month for the past 3 months
* No concurrent NSAIDs (e.g., mesalamine, olsalazine, azodisalicylate, salsalate, sulfasalazine)
* Aspirin for cardiac reasons allowed (81 mg/day or 325 mg twice/week)References
Publications (0)
Data not yet available
No reference posted for this study.