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. Author manuscript; available in PMC: 2012 Oct 2.
Published in final edited form as: Aliment Pharmacol Ther. 2008 Nov 8;29(3):235–246. doi: 10.1111/j.1365-2036.2008.03885.x

Table 5.

Study Design and Results of RCTs

Article Study Design Key Inclusion (I)/Exclusion (E) Criteria Tx Time Formulation per capsule Dose/Timing/Confounders (Lipase USP) Per Meal End Point Results
Borowitz et al, 2006 [10]

  • Dose Related

  • High Fat Diet

 I: Adults

  • Criteria for PI

 14 days ALTU-135 (Bacterial cross- linked crystallized) Groupl:5000
Group2:25000
Group3:100000
Meals and snacks.		 72 hr CFA (%) 72 hr CFA (%)
1 n=39 2 n=41 3 n=37
Pre-Tx 55±17.5 55.6±20.3 52.2±19.1
On-Tx 56.2±18.2 67±18.1 69.7±17.9
No Diff SS SS
O'keefe et al, 2001 [12]

  • Placebo

  • Specific diet

 I: Age >18

  • Criteria for Chronic Pancreatitis.

  • Criteria for Pancreatic Insufficiency.


E: Per text		 14 day Pancreatin (EC; MMSP)
Lipase 10000 USP
Amylase 33200 USP
Proteases 37500 USP		 40000 Meals
20000 Snack		 CFA (%) CFA (%)
Control n=14 Tx n=15
Before Tx 60.28 ± 0.1 54.0 ± 9.7 ND
After Tx 80.8± 3.8 SS
72hr FFE (g/day) 72 hr FFE (g/day)
Control n=14 Tx n=15
Before Tx 44.3 ± 9.9 48.0 ± 10.6 ND
After Tx 20.3±4.3 SS
72 hr Fecal Wt (g/day) 72 hr Fecal Wt (g/day)
Control n=14 Tx n=15
Before Tx 379 ± 65 360 ± 64 ND
After Tx 267 ± 44 SS
Safdi et al, 2006 [13]

  • Placebo

  • 100g fat diet

 I: Age> 18 years

  • Criteria for Pancreatic Insufficiency.


E:Per text		 2 week washout
2 week treatment		 Creon 10 (EC; MMSP)
Lipase 10000 USP
Amylase 33200 USP
Protease 37500 USP		 40000 Meals
20000 Snack		 72hr CFA (%) (SE) 72 hr CFA (%) (SE)
Control n=14 Tx n=12
Before Tx 55.9 (3.6) 49.9 (8.8) ND
After Tx 68.0 (4.6) 86.6 (2.7) SS
Daily FFE (g/day) Daily FFE (g/day)
Control n=14 Tx n=12
Before Tx 63.1 (7.2) 75.1 (18.4) ND
After Tx 51.8 (9.4) 18.6 (4.0) SS
Stern et al, 2000 [11]

  • Placebo

  • 100g fat diet

 I: Age≥18 years

  • Criteria for Chronic Pancreatitis.

  • Criteria for Pancreatic Insufficiency.


E: Per Text
I:7–18 years
Criteria as Above		 1–2 weeks open label
1 weeks double blinded		 Creon 20 (EC; MMSP)
Lipase 20000 USP
Amylase 66400 USP
Protease 75000 USP		 Varying doses to optimize digestion. 72hr CFA (%) (SEM) 72 hr CFA (%) (SEM)
Control n=18 Tx n=18
Open Lbl 87.8 (1.2) 89.2 (1.1) ND
DB Tx 50.9 (7.3) 87.2 (1.7) SS
72hr CFA (%) (SEM)
Control n=18 Tx n=20
Open Lbl 86.64 (1.02) 87.36 (1.14) ND
DB Tx 52.15 (5.61) 84.11 (2.22) SS