NCT01427725 is a clinical trial of Lipacreon in Exocrine Pancreatic Insufficiency, sponsored by Mylan Inc..

Who is sponsoring NCT01427725?

NCT01427725 is sponsored by Mylan Inc..

What drugs are being tested in NCT01427725?

Interventions in NCT01427725: Lipacreon.

What condition does NCT01427725 study?

NCT01427725 studies Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases.

Is NCT01427725 still recruiting?

NCT01427725 is currently completed. Last updated 9 March 2022.

Are results published for NCT01427725?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-03-09 · How we verify

NCT01427725

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Pancreatectomy and Other Conditions Except Cystic Fibrosis

Completed Results posted Last updated 9 March 2022

What this trial tests

trial testing Lipacreon in Exocrine Pancreatic Insufficiency in 579 participants. Completed in 1 April 2015.

Timeline

1 September 2011

Primary endpoint
1 January 2015

1 April 2015

Quick facts

Lead sponsor	Mylan Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	579
Start date	1 September 2011
Primary completion	1 January 2015
Estimated completion	1 April 2015
Sites	189 locations across Japan

Drugs / interventions tested

Lipacreon — full drug profile →

Conditions studied

Exocrine Pancreatic Insufficiency — all drugs for Exocrine Pancreatic Insufficiency →
Pancreatic Diseases — all drugs for Pancreatic Diseases →
Digestive System Diseases — all drugs for Digestive System Diseases →

Sponsor

Mylan Inc. — full company profile →

Who can join

Adults 1 to 99, any sex, with Exocrine Pancreatic Insufficiency or Pancreatic Diseases. 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.

Number of Patients With Adverse Drug Reaction
Time frame: At week 52
An adverse event (AE) was defined as any unfavourable or unintended disease, or symptom or sign of such a disease, or abnormal laboratory finding that occurred in a patient who received Lipacreon, whether or not considered related to the medicinal product. Also, an AE for which the relationship with Lipacreon could not be ruled out was regarded as an adverse drug reaction (ADR). 1. Related : Ther

Sponsor's own description

This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long term in order to evaluate the effective and safe use of LipaCreon.

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:

Other recruiting trials for Exocrine Pancreatic Insufficiency

Currently open trials in the same condition.

NCT05710315 — Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure · NA · recruiting
NCT06477159 — Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency · Phase 4 · recruiting
NCT05112328 — The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding · NA · recruiting

Other Mylan Inc. trials

Trials by the same sponsor.

NCT05051527 — Study to Evaluate the Effectiveness of Legalon® · completed
NCT05158972 — Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients · completed
NCT05030025 — Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg) · EARLY_PHASE1 · completed
NCT04976868 — Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis · completed
NCT05000541 — Observation of the Effects of Guideline-driven Lifestyle Interventions, Including Use of a Red-yeast Based Nutraceutical · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01427725 (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 Mylan Inc.
Last refreshed: 9 March 2022

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/NCT01427725.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing