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NCT01710644
A Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Phase 1/Phase 2 trial testing Burlulipase in Pancreatic Insufficiency in 35 participants. Completed in 1 August 2014.
1 July 2014
Quick facts
| Lead sponsor | Nordmark Arzneimittel GmbH & Co. KG |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 1 May 2013 |
| Primary completion | 1 July 2014 |
| Estimated completion | 1 August 2014 |
| Sites | 9 locations across United States |
Drugs / interventions tested
- Burlulipase — full drug profile →
- Placebo (Caramel in sterile water) — full drug profile →
Conditions studied
- Pancreatic Insufficiency — all drugs for Pancreatic Insufficiency →
- Cystic Fibrosis — all drugs for Cystic Fibrosis →
- Digestive System Diseases — all drugs for Digestive System Diseases →
- Lung Diseases — all drugs for Lung Diseases →
Sponsor
Nordmark Arzneimittel GmbH & Co. KG — full company profile →
Who can join
12 and older, any sex, with Pancreatic Insufficiency or Cystic Fibrosis. 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.
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To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF, where the primary variable is coefficient of fat absorption (CFA%)
Time frame: 72 hrs
Sponsor's own description
The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Safety and Efficacy of a Novel Microbial Lipase in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis: A Randomized Controlled Clinical Trial.
Heubi JE, Schaeffer D, Ahrens RC, Sollo N, et al · · 2016 · cited 16× · PMID 27297209 · DOI 10.1016/j.jpeds.2016.05.049
Verify or expand the search:
- PubMed search for NCT01710644
- 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.
- NCT05466838 — PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial · NA · active not recruiting
- NCT04731272 — GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance · Phase 2 · recruiting
Other Nordmark Arzneimittel GmbH & Co. KG trials
Trials by the same sponsor.
- NCT03076411 — Pepsin in Patients With Functional Dyspepsia · completed
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 NCT01710644 (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 Nordmark Arzneimittel GmbH & Co. KG
- Last refreshed: 3 June 2016
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/NCT01710644.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing