Last reviewed · How we verify
NCT01012908
Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency
Phase 2/Phase 3 trial testing Norzyme - Bergamo in Pancreatic Insufficiency in 25 participants. Status unknown.
1 April 2010
Quick facts
| Lead sponsor | Azidus Brasil |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 1 March 2010 |
| Primary completion | 1 April 2010 |
| Estimated completion | 1 June 2011 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Norzyme - Bergamo
- Creon (PROTEASE)) — full drug profile →
Conditions studied
- Pancreatic Insufficiency — all drugs for Pancreatic Insufficiency →
Sponsor
Azidus Brasil — full company profile →
Who can join
18 and older, any sex, with Pancreatic Insufficiency. 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.
-
Amount of fat in the stools of 72 hours of medication use between the two treatments.
Time frame: First period: 12th, 13th and14th day. Second period (After crossover medication): 12th, 13th and14th day
Sponsor's own description
The primary objective of this clinical trial is to demonstrate non-inferiority clinical development of pancreatic enzymes from Laboratory Bergamo (Norzyme ®) in relation to pancreatic enzymes from Solvay Pharmaceuticals (Creon ®), by comparing the average amount of lipids in the feces of 72 hours after 14 days of treatment with each drug.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01012908
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pancreatic Insufficiency
Currently open trials in the same condition.
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- NCT04731272 — GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance · Phase 2 · recruiting
Other Azidus Brasil trials
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 NCT01012908 (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 Azidus Brasil
- Last refreshed: 26 October 2010
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/NCT01012908.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing