Irritable Bowel SyndromePhase 3NCT00220090
DARWIN Study: A Randomization/Withdrawal Efficacy Study of Dexloxiglumide in Constipation-Predominant Irritable Bowel Syndrome (C-IBS)
A Phase 3 study testing dexloxiglumide in people with Irritable Bowel Syndrome, run by Rottapharm at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- dexloxiglumide
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2003to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rome II criteria for IBS and manifesting supportive symptoms for the sub-classification of C-IBS, with a disease of at least moderate severity.
Who cannot join
- standard exclusions apply
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Department of Medicine Wythenshawe Hospital
Manchester
About this study
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.
Read more
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- dexloxiglumide
- Keywords
- Irritable Bowel Syndrome, Cholecystokinin, Dexloxiglumide, Randomized/withdrawal
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexloxiglumideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (7)
abdominal discomfort/pain
bloating
straining
incomplete evacuation
urgency
stool frequency and consistency
quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Rottapharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter J Whorwell, MD FRCP, Principal investigator, Academic Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Southmoor Road, Manchester, M23 9LT, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220090
- Sponsor's protocol ID
- DEX-MD-05
- Other IDs
- DARWIN Study
- Status last verified
- May 2008
- First submitted
- 13 Sep 2005
- Last updated
- 14 May 2008
- Results posted
- No
Publications
Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, Muller-Lissner SA. Functional bowel disorders and functional abdominal pain. Gut. 1999 Sep;45 Suppl 2(Suppl 2):II43-7. doi: 10.1136/gut.45.2008.ii43.
PubMed 10457044Veldhuyzen 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(Suppl 2):II69-77. doi: 10.1136/gut.45.2008.ii69.
PubMed 10457048The 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.
Camilleri M. Management of the irritable bowel syndrome. Gastroenterology. 2001 Feb;120(3):652-68. doi: 10.1053/gast.2001.21908.
PubMed 11179242
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00220090
- Acronym / sponsor ID
- DEX-MD-05
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Cholecystokinin, Dexloxiglumide, Randomized/withdrawal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- RottapharmIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Sep 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rome II criteria for IBS and manifesting supportive symptoms for the sub-classification of C-IBS, with a disease of at least moderate severity.
Key exclusion criteria (1 listed)
- standard exclusions apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexloxiglumide | Drug | – |
Primary outcome
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
7 secondary outcomes
abdominal discomfort/pain
bloating
straining
incomplete evacuation
urgency
stool frequency and consistency
quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2008.
- Background: PubMed 10457044Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, Muller-Lissner SA. Functional bowel disorders and functional abdominal pain. Gut. 1999 Sep;45 Suppl 2(Suppl 2):II43-7. doi: 10.1136/gut.45.2008.ii43.
- Background: PubMed 10457048Veldhuyzen 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(Suppl 2):II69-77. doi: 10.1136/gut.45.2008.ii69.
- BackgroundThe 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.
- Background: PubMed 11179242Camilleri M. Management of the irritable bowel syndrome. Gastroenterology. 2001 Feb;120(3):652-68. doi: 10.1053/gast.2001.21908.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Whorwell, MD FRCP principal investigator
Academic Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Southmoor Road, Manchester, M23 9LT, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexloxiglumide in people with Irritable Bowel Syndrome, run by Rottapharm at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00220090, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2008.