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NCT01587534
Phase 2 Study of Randomized Controlled Trial of Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer
Phase 2 trial testing Norzyme in Pancreatic Cancer in 67 participants. Completed in 1 December 2014.
1 December 2014
Quick facts
| Lead sponsor | National Cancer Center, Korea |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 1 October 2011 |
| Primary completion | 1 December 2014 |
| Estimated completion | 1 December 2014 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Norzyme — full drug profile →
Conditions studied
- Pancreatic Cancer — all drugs for Pancreatic Cancer →
Sponsor
National Cancer Center, Korea
Who can join
18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
the change in body weight at eight weeks after the randomisation
Time frame: at baseline and 4, 8 week, 24 week
the percentage change in body weight at eight weeks after the randomisation
Sponsor's own description
The investigators planned a prospective, randomized, placebo controlled trial to test the hypothesis that weight loss in patients with unresectable pancreatic cancer with occlusion of the pancreatic duct can be reduced or prevented by pancreatic enzyme replacement therapy in combination with dietary counseling.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy of pancreatic exocrine replacement therapy for patients with unresectable pancreatic cancer in a randomized trial.
Woo SM, Joo J, Kim SY, Park SJ, et al · · 2016 · cited 37× · PMID 27618657 · DOI 10.1016/j.pan.2016.09.001
Verify or expand the search:
- PubMed search for NCT01587534
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other National Cancer Center, Korea trials
Trials by the same sponsor.
- NCT07399561 — Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy · NA · not yet recruiting
- NCT07121478 — Patients With High-grade Pancreatic Neuroendocrine Tumors · Phase 2 · enrolling by invitation
- NCT07171528 — Secondary Cytoreductive Surgery After Chemotherapy for Recurrent Epithelial Ovarian Cancer · Phase 2 · recruiting
- NCT07125924 — Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer · NA · not yet recruiting
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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 NCT01587534 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Center, Korea
- Last refreshed: 13 April 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/NCT01587534.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing