DARWIN Study: A Randomization/Withdrawal Efficacy Study of Dexloxiglumide in Constipation-Predominant Irritable Bowel Syndrome (C-IBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220090
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 14, 2008
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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 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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: dexloxiglumide Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : July 2003
Actual Primary Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. abdominal discomfort/pain
  2. bloating
  3. straining
  4. incomplete evacuation
  5. urgency
  6. stool frequency and consistency
  7. quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00220090

United Kingdom
Academic Department of Medicine Wythenshawe Hospital
Manchester, United Kingdom
Sponsors and Collaborators
Principal Investigator: Peter J Whorwell, MD FRCP Academic Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Southmoor Road, Manchester, M23 9LT, United Kingdom

Publications: Identifier: NCT00220090     History of Changes
Other Study ID Numbers: DEX-MD-05
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 14, 2008
Last Verified: May 2008

Keywords provided by Rottapharm:
Irritable Bowel Syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases