NCT01427712 is a clinical trial of Pancrelipase in Cystic Fibrosis, sponsored by Mylan Inc..

Who is sponsoring NCT01427712?

NCT01427712 is sponsored by Mylan Inc..

What drugs are being tested in NCT01427712?

Interventions in NCT01427712: Pancrelipase.

What condition does NCT01427712 study?

NCT01427712 studies Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases.

Is NCT01427712 still recruiting?

NCT01427712 is currently completed. Last updated 9 March 2022.

Are results published for NCT01427712?

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

NCT01427712

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

Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Completed Results posted Last updated 9 March 2022

What this trial tests

trial testing Pancrelipase in Cystic Fibrosis in 24 participants. Completed in 1 March 2018.

Timeline

1 August 2011

Primary endpoint
1 March 2018

1 March 2018

Quick facts

Lead sponsor	Mylan Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	24
Start date	1 August 2011
Primary completion	1 March 2018
Estimated completion	1 March 2018
Sites	21 locations across Japan

Drugs / interventions tested

Pancrelipase — full drug profile →

Conditions studied

Cystic Fibrosis — all drugs for Cystic Fibrosis →
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 Cystic Fibrosis or Exocrine 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.

Number of Patients With Adverse Drug Reaction
Time frame: From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 7 years in the study completers (From date of dosage start, up to 7 years).
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 due to cystic fibrosis receiving the treatment with LipaCreon 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 trials of Pancrelipase

Trials testing the same drug.

NCT03859869 — A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Ins · Phase 4 · terminated
NCT03924947 — A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manuf · Phase 4 · completed
NCT03469258 — Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma · Phase 2 · terminated

Other recruiting trials for Cystic Fibrosis

Currently open trials in the same condition.

NCT07437105 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants · Phase 1 · recruiting
NCT07283770 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants · Phase 1 · recruiting
NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine · recruiting
NCT06810167 — Assessing Tenapanor as a Treatment of CF-related Constipation. · Phase 3 · recruiting
NCT06962852 — A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI · Phase 1, PHASE2 · active not 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 NCT01427712 (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/NCT01427712.

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