Phase 3 N=40 Randomized Quadruple-blind Treatment

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

Exocrine Pancreatic Insufficiency · Steatorrhea · Malabsorption Syndromes · Cystic Fibrosis

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View on ClinicalTrials.gov: NCT00662675 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2010

Primary outcome: Primary: Change in the Coefficient of Fat Absorption (COA-fat Percent) — -34.1; -1.5 percentage COA-fat — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Pancrease MT 10.5, or MT 21 (Drug); Placebo for Pancrease MT 10.5 or MT 21 (Drug)
Age: Pediatric, Adult · 7+ yrs
Sex: All
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Coefficient of Fat Absorption (COA-fat Percent)	-34.1; -1.5	<0.001 sig
SECONDARY Change in Percent COA-Protein (Nitrogen)	-26.5; 1.3	<0.001 sig
SECONDARY Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase	55; 20; 30; 15; 15; 5	—

Summary

The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic insufficiency (EPI).

Eligibility Criteria

Inclusion Criteria

Have a diagnosis of CF documented by sweat chloride results (>60 mmol/L) and require pancreatic enzyme replacement therapy (PERT) to control clinical symptoms of EPI (nausea, vomiting, bloating, diarrhea, and abdominal pain) with a history of excess fat in the feces
Have documentation of an abnormal COA-fat and a fecal elastase result of <100 micrograms fecal elastase/gram stool
Must be on a stable diet and dose of pancreatic enzyme supplementation that has provided satisfactory symptom control for at least the past 1 month

Exclusion Criteria

No extreme physical wasting with loss of weight and muscle mass
No severe, acute, or chronic pulmonary disease unrelated to complications of CF
No worsening of pulmonary disease in past 30 days
No use of drugs known to affect blood uric acid concentrations (e.g., aspirin, diflunisal, allopurinol, probenecid, thiazide diuretics, phenylbutazone, sulfinpyrazone)
No known congenital (present at birth) abnormalities of the gastrointestinal tract, heart, or liver
No distal intestinal obstruction syndrome (DIOS)

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Data sourced from ClinicalTrials.gov (NCT00662675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.