Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220090
Status:
COMPLETED
Last Update Posted:
2008-05-14
First Post:
2005-09-13
Brief Title:
DARWIN Study A RandomizationWithdrawal Efficacy Study of Dexloxiglumide in Constipation-Predominant Irritable Bowel Syndrome C-IBS
Sponsor:
Rottapharm
Organization:
Rottapharm
Study Overview
Official Title:
A 24-wk Prospective db Placebo Controlled Parallel Group Multicenter RandomizedWithdrawal Efficacy and Safety Study of Dexloxiglumide for the Relief of Symptoms in Patients With Constipation-Predominant Irritable Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2008-05
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:
Irritable Bowel Syndrome IBS is the most commonly identified functional gastrointestinal disorder affecting 10-20 of the population in the Western world seen predominantly in females and with a negative impact on quality of life characterized by recurrent and often disabling abdominal pain associated with altered frequency or appearance or passage of the stool
IBS aetiology is unknown and its treatment remains largely empirical and directed to the relief of symptoms One possible target for IBS treatment has been identified in drugs that modulate the action of Cholecystokinin CCK a peptide gut hormone implicated in the regulation of motor and sensory functions at various levels of the gastrointestinal tract
The biological actions of CCK in the gastrointestinal tract are mediated by CCK1-receptors
Dexloxiglumide is an oral potent and selective antagonist of CCK1-receptors The mechanism by which dexloxiglumide might be beneficial in IBS is its ability to modulate visceral hypersensitivity and gut dysmotility
The DARWIN study has been designed to confirm the efficacy of dexloxiglumide according to a so-called randomizedwithdrawal design In this design all participants start the study treatment and only improved patients the responders are randomized to active treatment or placebo expecting a more frequent andor a more rapid relapse of their symptoms in patients randomised to placebo than those on active
Female and male patients aged 18-70 yrs meeting IBS diagnostic criteria whose main complain is constipation with a disease of at least moderate severity will receive dexloxiglumide or placebo during a double-blind treatment phase of 24 weeks following a first treatment of up to 12 wks during which patients will have to qualify as responders to the study treatment
The responder status of each patient over each 4-wk assessment period will be based on a weekly global patient-based assessment of relief and control of symptoms using a telephoneinternet-based diary
Additional secondary efficacy parameters will include effect of treatment on IBS cardinal symptoms eg abdominal discomfortpain bloating straining incomplete evacuation urgency stool frequency and consistency on rescue laxative consumption and on quality of life
Standard safety parameters include vital signs adverse event reporting physical examination routine laboratory screen 12-lead ECG and gallbladder ultrasound
IBS aetiology is unknown and its treatment remains largely empirical and directed to the relief of symptoms One possible target for IBS treatment has been identified in drugs that modulate the action of Cholecystokinin CCK a peptide gut hormone implicated in the regulation of motor and sensory functions at various levels of the gastrointestinal tract
The biological actions of CCK in the gastrointestinal tract are mediated by CCK1-receptors
Dexloxiglumide is an oral potent and selective antagonist of CCK1-receptors The mechanism by which dexloxiglumide might be beneficial in IBS is its ability to modulate visceral hypersensitivity and gut dysmotility
The DARWIN study has been designed to confirm the efficacy of dexloxiglumide according to a so-called randomizedwithdrawal design In this design all participants start the study treatment and only improved patients the responders are randomized to active treatment or placebo expecting a more frequent andor a more rapid relapse of their symptoms in patients randomised to placebo than those on active
Female and male patients aged 18-70 yrs meeting IBS diagnostic criteria whose main complain is constipation with a disease of at least moderate severity will receive dexloxiglumide or placebo during a double-blind treatment phase of 24 weeks following a first treatment of up to 12 wks during which patients will have to qualify as responders to the study treatment
The responder status of each patient over each 4-wk assessment period will be based on a weekly global patient-based assessment of relief and control of symptoms using a telephoneinternet-based diary
Additional secondary efficacy parameters will include effect of treatment on IBS cardinal symptoms eg abdominal discomfortpain bloating straining incomplete evacuation urgency stool frequency and consistency on rescue laxative consumption and on quality of life
Standard safety parameters include vital signs adverse event reporting physical examination routine laboratory screen 12-lead ECG and gallbladder ultrasound
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DARWIN Study | None | None | None |