Completed PHASE3 INTERVENTIONAL 2-arm NCT00662675

A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

A Randomized Double-blind (Withdrawal) Phase 3 Study to Evaluate the Efficacy and Tolerability of Pancrelipase MT Capsules Compared With Placebo in the Treatment of Subjects With Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Conditions Cystic Fibrosis Exocrine Pancreatic Insufficiency Malabsorption Syndromes Steatorrhea

Interventions Pancrease MT 10.5, or MT 21 Placebo for Pancrease MT 10.5 or MT 21

Updated 9 times since 2017 Last updated: Apr 24, 2014 Started: Aug 31, 2008 Primary completion: Feb 28, 2009 Completion: Feb 28, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00662675, this PHASE3 trial focuses on Cystic Fibrosis and Exocrine Pancreatic Insufficiency and remains completed. Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., it has been updated 9 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2023 — Jul 2024 [monthly]

Completed PHASE3
Dec 2022 — Jan 2023 [monthly]

Completed PHASE3

▶ Show 4 earlier versions

Jan 2021 — Dec 2022 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Aug 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Data source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Cincinnati, United States , Cleveland, United States , Las Vegas, United States , Long Beach, United States , Long Branch, United States , Los Angeles, United States , Louisville, United States , Oklahoma City, United States , Orlando, United States , Pittsburgh, United States and 1 more location