Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006063
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-07-05
Brief Title:
Randomized Study of Pancrelipase With Bicarbonate PANCRECARB Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Compare the efficacy of enteric coated pancrelipase with bicarbonate PANCRECARB capsules versus the patients usual enteric coated pancreatic enzyme without bicarbonate in decreasing fecal fat and nitrogen losses in patients with cystic fibrosis
I Compare the efficacy of enteric coated pancrelipase with bicarbonate PANCRECARB capsules versus the patients usual enteric coated pancreatic enzyme without bicarbonate in decreasing fecal fat and nitrogen losses in patients with cystic fibrosis
Detailed Description:
PROTOCOL OUTLINE This is a randomized multicenter study In the first treatment period patients are randomized to one of two treatment arms
Arm I Patients receive enteric coated pancrelipase with bicarbonate PANCRECARB capsules before meals and snacks for 7 consecutive days
Arm II Patients receive their usual enteric coated pancreatic enzyme without bicarbonate capsule before meals and snacks for 7 consecutive days
Patients receive approximately 50 of their usual lipase dose during treatment Food intake is recorded on days 1-3 food intake is weighed and recorded on days 4-7 and stools are collected over 72 hours on days 5-7 to determine fecal fat and nitrogen excretion Anthropometric measurements including height weight and skinfolds are assessed
In the second treatment period patients are switched to the alternate treatment arm after a 3 day washout period Patients receive the opposing treatment as per protocol
Arm I Patients receive enteric coated pancrelipase with bicarbonate PANCRECARB capsules before meals and snacks for 7 consecutive days
Arm II Patients receive their usual enteric coated pancreatic enzyme without bicarbonate capsule before meals and snacks for 7 consecutive days
Patients receive approximately 50 of their usual lipase dose during treatment Food intake is recorded on days 1-3 food intake is weighed and recorded on days 4-7 and stools are collected over 72 hours on days 5-7 to determine fecal fat and nitrogen excretion Anthropometric measurements including height weight and skinfolds are assessed
In the second treatment period patients are switched to the alternate treatment arm after a 3 day washout period Patients receive the opposing treatment as per protocol
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DIGEST-97-0001-1B | None | None | None |
| IUMC-9506-10 | None | None | None |