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NCT00004414
Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
NA trial testing sincalide in Cholestasis in 252 participants. Completed in 1 June 2002.
Quick facts
| Lead sponsor | University of Michigan |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 252 |
| Start date | 1 September 1997 |
| Estimated completion | 1 June 2002 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- sincalide (SINCALIDE) — full drug profile →
Conditions studied
- Cholestasis — all drugs for Cholestasis →
Sponsor
University of Michigan
Who can join
Under 30 Days, any sex, with Cholestasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely premature newborns on long term parenteral nutrition and given either sincalide or placebo. II. Compare morbidity and mortality rates in this patient population. III. Evaluate ultrasonographic images of the hepatobiliary tree during and 1 to 2 years after the administration of sincalide or placebo to assess the development of biliary sludge and biliary stone formation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00004414
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cholestasis
Currently open trials in the same condition.
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- NCT05582447 — Osmotic Fragility in Red Blood Cells of Pediatric Patients With Cholestatic Liver Disease · active not recruiting
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00004414 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Michigan
- Last refreshed: 24 March 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00004414.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing