Irritable Bowel Syndrome With Diarrhea (IBS-D)Phase 2NCT00394173
Efficacy, Safety and Tolerability of DNK333 (25 mg Bid) in Women With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
A Phase 2 study testing DNK333 in people with Irritable Bowel Syndrome With Diarrhea (IBS-D), run by Novartis at 43 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea (IBS-D)
- What is being tested?
- DNK333
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 43 sitesin 2 countries
- Study dates
- Sep 2006to Oct 2007
- Phase
- Phase 2
- 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 65 years
- Women only
- Adult, Older adult
Who may be able to join
- Women of 18 - 65 years of age with IBS-D as defined by the Rome II criteria.
- The Rome II criteria is a system used for diagnosing functional gastrointestinal disorders such as irritable bowel syndrome. It involves completing of a questionnaire about gastrointestinal symptoms.
- Patients who are 50 years of age and older must have had a colonoscopy OR a flexible sigmoidoscopy plus a double-contrast barium enema within the past 5 years, which demonstrated no clinically significant findings.
- Clinically significant findings may include but are not limited to malignant tumors, multiple (≥3) or advanced adenomas, inflammatory bowel disease, diverticulitis, ischaemic colitis, lymphocytic colitis, or collagenous colitis.
- Patients must report ≥ 3 days with IBS-related abdominal pain/discomfort plus at least 3 days of 2 or more of the following events during the baseline period:
- ≥ 3 bowel movements/day
- Bowel urgency
- Loose or watery stool
Who cannot join
- Patients who answer "yes" to either or both of the two weekly satisfaction questions during the baseline period. The questions are: (1) Over the past week did you have satisfactory relief of your IBS-related abdominal pain/discomfort? (2) Over the last week did you have satisfactory relief of your overall IBS-D symptoms?
- Patients with hard or lumpy stools for more than one day during the baseline period.
- Lactose intolerant patients relieved on a lactose free diet.
- Use of antidepressants (tricyclic, SSRI etc), opioid analgesic drugs or drugs specifically affecting bowel motility during the course of the trial.
- Women of child-bearing potential who do not use an acceptable methods of contraception.
- Pregnant or nursing (lactating) women.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States37 sites
Investigative Site
Arlington Heights, Illinois, 60005
Investigative Site
Bellevue, Washington, 98004
Investigative Site
Boca Raton, Florida, 33486
Investigative Site
Boston, Massachusetts, 02215
Investigative Site
Bristol, Connecticut, 06010
Investigative Site
Buffalo, New York, 14215
Investigative Site
Chattanooga, Tennessee, 37404
Investigative Site
Chesapeake, Virginia, 23320-1706
Investigative Site
Cincinnati, Ohio, 45219
Investigative Site
Colorado Springs, Colorado, 80904
Investigative Site
Elkin, North Carolina, 28621
Investigative Site
Everett, Washington, 98208
Investigative Site
Gainesville, Florida, 32256
Investigative Site
Great Neck, New York, 11023-2432
Investigative Site
Hartford, Connecticut, 06010
Investigative Site
Hollywood, Florida, 33021
Investigative Site
Jacksonville, Florida, 782091744
Investigative Site
Lake Jackson, Texas, 77566
Investigative Site
Los Angeles, California, 90045-3119
Investigative Site
Mexico, Missouri, 65265-3726
Investigative Site
Miami, Florida, 33173
Investigative Site
Monroe, Washington, 98208
Investigative Site
New Smyrna Beach, Florida, 32168-7327
Investigative Site
North Little Rock, Arkansas, 72114
Investigative Site
Oklahoma City, Oklahoma, 73104
Investigative Site
Orange, California, 92869
Investigative Site
Portland, Oregon, 97220
Investigative Site
Riverside, California, 92506
Investigative Site
Rockford, Illinois, 61107
Investigative Site
Sacramento, California, 95825
Investigative Site
Salt Lake City, Utah, 84102
Investigative Site
San Antonio, Texas, 78209-1744
Investigative Site
San Diego, California, 92108
Investigative Site
Seattle, Washington, 98101
Investigative Site
Tampa, Florida, 33607
Investigative Site
Tucson, Arizona, 85712
Investigative Site
Wellesley Hills, Massachusetts, 02481-2106
Canada6 sites
Investigative Site
Calgary, Alberta, T2N 4N1
Investigative Site
Hamilton, Ontario, L8N 3Z5
Investigative Site
Montreal, Quebec, H2X 3J4
Investigative Site
Québec, Quebec, G1S 4L8
Investigative Site
Sherbrooke, Quebec, J1H 4J6
Investigative Site
St. John's, Newfoundland and Labrador, A1E 2E2
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of DNK333 25mg b.i.d. Given Orally for 4 Weeks in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients.
- Being tested
- DNK333, Placebo
- Keywords
- IBS, diarrhea, gastrointestinal functional disorder, IBS-D
- Medical subject headings
- Diarrhea, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNK333Drug
DNK333 25mg b.i.d. given orally for 4 weeks
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: DNK333 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfactory relief of IBS-related abdominal pain/discomfort
Measured: 4 weeks
Satisfactory relief of overall IBS-D symptoms
Measured: 4 weeks
Secondary outcomes (5)
Occurrence and control of bowel urgency
Measured: 4 weeks
Change in stool frequency
Measured: 4 weeks
Severity of abdominal bloating
Measured: 4 weeks
Severity of abdominal pain/discomfort
Measured: 4 weeks
Safety
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome With Diarrhea (IBS-D)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals Corp., Study chair, NPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394173
- Sponsor's protocol ID
- CDNK333B2202
- Status last verified
- Feb 2017
- First submitted
- 30 Oct 2006
- Last updated
- 27 Feb 2017
- Results posted
- No
Publications
Zakko S, Barton G, Weber E, Dunger-Baldauf C, Ruhl A. Randomised clinical trial: the clinical effects of a novel neurokinin receptor antagonist, DNK333, in women with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2011 Jun;33(12):1311-21. doi: 10.1111/j.1365-2036.2011.04656.x. Epub 2011 Apr 20.
PubMed 21507028
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of DNK333 25mg b.i.d. Given Orally for 4 Weeks in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
- ClinicalTrials.gov ID
- NCT00394173
- Acronym / sponsor ID
- CDNK333B2202
- Keywords
- IBS, diarrhea, gastrointestinal functional disorder, IBS-D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 31 Oct 2006 (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.
The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DNK333 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women of 18 - 65 years of age with IBS-D as defined by the Rome II criteria.
- The Rome II criteria is a system used for diagnosing functional gastrointestinal disorders such as irritable bowel syndrome. It involves completing of a questionnaire about gastrointestinal symptoms.
- Patients who are 50 years of age and older must have had a colonoscopy OR a flexible sigmoidoscopy plus a double-contrast barium enema within the past 5 years, which demonstrated no clinically significant findings.
- Clinically significant findings may include but are not limited to malignant tumors, multiple (≥3) or advanced adenomas, inflammatory bowel disease, diverticulitis, ischaemic colitis, lymphocytic colitis, or collagenous colitis.
- Patients must report ≥ 3 days with IBS-related abdominal pain/discomfort plus at least 3 days of 2 or more of the following events during the baseline period:
Key exclusion criteria (7 listed)
- Patients who answer "yes" to either or both of the two weekly satisfaction questions during the baseline period. The questions are: (1) Over the past week did you have satisfactory relief of your IBS-related abdominal pain/discomfort? (2) Over the last week did you have satisfactory relief of your overall IBS-D symptoms?
- Patients with hard or lumpy stools for more than one day during the baseline period.
- Lactose intolerant patients relieved on a lactose free diet.
- Use of antidepressants (tricyclic, SSRI etc), opioid analgesic drugs or drugs specifically affecting bowel motility during the course of the trial.
- Women of child-bearing potential who do not use an acceptable methods of contraception.
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 |
|---|---|---|
| DNK333DNK333 25mg b.i.d. given orally for 4 weeks | Drug | 1 |
| PlaceboMatching placebo | Drug | 2 |
Primary outcome
Satisfactory relief of IBS-related abdominal pain/discomfort
Time frame: 4 weeks
Satisfactory relief of overall IBS-D symptoms
Time frame: 4 weeks
5 secondary outcomes
Occurrence and control of bowel urgency
Time frame: 4 weeks
Change in stool frequency
Time frame: 4 weeks
Severity of abdominal bloating
Time frame: 4 weeks
Severity of abdominal pain/discomfort
Time frame: 4 weeks
Safety
Time frame: 4 weeks
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 27 Feb 2017.
- Results publication: PubMed 21507028Zakko S, Barton G, Weber E, Dunger-Baldauf C, Ruhl A. Randomised clinical trial: the clinical effects of a novel neurokinin receptor antagonist, DNK333, in women with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2011 Jun;33(12):1311-21. doi: 10.1111/j.1365-2036.2011.04656.x. Epub 2011 Apr 20.
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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.
Novartis Pharmaceuticals Corp. study chair
NPC
43 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DNK333 in people with Irritable Bowel Syndrome With Diarrhea (IBS-D), run by Novartis at 43 sites in 2 countries.
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 8 inclusion and 7 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 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Satisfactory relief of IBS-related abdominal pain/discomfort (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT00394173, which also lists 1 linked publication.
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 27 Feb 2017.