Irritable Bowel Syndrome Clinical Trial
Official title:
A 24-wk, Prospective, d/b, Placebo Controlled, Parallel Group, Multicenter, Randomized/Withdrawal Efficacy and Safety Study of Dexloxiglumide for the Relief of Symptoms in Patients With Constipation-Predominant Irritable Bowel Syndrome
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 randomized/withdrawal 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 and/or 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
telephone/internet-based diary.
Additional secondary efficacy parameters will include: effect of treatment on IBS cardinal
symptoms (e.g. abdominal discomfort/pain, 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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | September 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Rome II criteria for IBS and manifesting supportive symptoms for the sub-classification of C-IBS, with a disease of at least moderate severity. Exclusion Criteria: - standard exclusions apply |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Academic Department of Medicine Wythenshawe Hospital | Manchester |
Lead Sponsor | Collaborator |
---|---|
Rottapharm |
United Kingdom,
Camilleri M. Management of the irritable bowel syndrome. Gastroenterology. 2001 Feb;120(3):652-68. Review. — View Citation
The European Agency for the Evaluation of the Medicinal Products (EMEA) - Committee for Proprietary Medicinal Products (CPMP). Draft "Points to consider on the Evaluation of Medicinal Products for the Treatment of Irritable Bowel Syndrome". Document N. CPMP/EWP/785/97 dated 25 April 2002.
Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, Müller-Lissner SA. Functional bowel disorders and functional abdominal pain. Gut. 1999 Sep;45 Suppl 2:II43-7. Review. — View Citation
Veldhuyzen van Zanten SJ, Talley NJ, Bytzer P, Klein KB, Whorwell PJ, Zinsmeister AR. Design of treatment trials for functional gastrointestinal disorders. Gut. 1999 Sep;45 Suppl 2:II69-77. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to relapse, i.e. loss of responder status, which is based on a global patient-based weekly assessment of relief and control of symptoms | |||
Secondary | abdominal discomfort/pain | |||
Secondary | bloating | |||
Secondary | straining | |||
Secondary | incomplete evacuation | |||
Secondary | urgency | |||
Secondary | stool frequency and consistency | |||
Secondary | quality of life |
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