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

This study has been completed.
Sponsor:
Information provided by:
Rottapharm
ClinicalTrials.gov Identifier:
NCT00220090
First received: September 13, 2005
Last updated: May 13, 2008
Last verified: May 2008

September 13, 2005
May 13, 2008
July 2003
September 2006   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00220090 on ClinicalTrials.gov Archive Site
  • abdominal discomfort/pain
  • bloating
  • straining
  • incomplete evacuation
  • urgency
  • stool frequency and consistency
  • quality of life
Same as current
Not Provided
Not Provided
 
DARWIN Study: A Randomization/Withdrawal Efficacy Study of Dexloxiglumide in Constipation-Predominant Irritable Bowel Syndrome (C-IBS)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Irritable Bowel Syndrome
Drug: dexloxiglumide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
September 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00220090
DEX-MD-05, DARWIN Study
Not Provided
Not Provided
Rottapharm
Not Provided
Principal Investigator: Peter J Whorwell, MD FRCP Academic Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Southmoor Road, Manchester, M23 9LT, United Kingdom
Rottapharm
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP