Irritable Bowel SyndromePhase 2NCT00230581
8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS
A Phase 2 study testing DDP225 in people with Irritable Bowel Syndrome, run by Dynogen Pharmaceuticals at 16 sites in 2 countries.
Trial summary
In this study, female patients with IBS-d will be treated for 8 weeks to assess the safety and effectiveness of DDP225 on GI transit and in reducing IBS symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- DDP225
- How many people
- 88 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Sep 2005to Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients from 18 to 65 years of age, inclusive.
- History of IBS-d for at least 6 months prior to the initial screening visit.
- Endoscopic/radiologic bowel evaluation to rule out cancer, obstruction, or other structural disease.
- The patient must have completed at least six days of assessments in the patient diary in the one week period prior to the second screening visit.
- Negative serum and urine pregnancy tests and post-partum for at least one year or not breast feeding at the initial screening visit and throughout the study. For patients able to bear children, an acceptable method of birth control must be used throughout the study. Patients unable to bear children must have documentation of such in the case report form (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
- Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol.
Who cannot join
- Serious underlying diseases, including psychiatric disorders or current history of conditions affecting bowel transit including biochemical or structural abnormalities, or GI surgery
- Clinically significant abnormal examination findings or laboratory tests
- Inability to stop taking certain medications, or a planned change in medication (including herbal remedies) which could interfere with study assessments
- Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
- Presence of a medical condition which could interfere with the interpretation of study data
- Significant use of nicotine or caffeine
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Canada11 sites
QE II Health Sciences Centre
Halifax, Nova Scotia
McMaster University Medical Centre
Hamilton, Ontario
St. Joseph's Healthcare
Hamilton, Ontario
Hotel Dieu Hospital
Kingston, Ontario
St. Joseph's Healthcare
London, Ontario
Meadowlands Family Health Centre
Ottawa, Ontario
Hopital St-Sacrement
Québec, Quebec
London Road Diagnostic Clinic
Sarnia, Ontario
Sarnia Institute of Clinical Research
Sarnia, Ontario
Canadian Phase Onward Inc.
Toronto, Ontario, M3H 5S4
Toronto Digestive Disease Associates, Inc.
Toronto, Ontario
United States5 sites
Long Island Gastrointestinal Research
Great Neck, New York, 11023
Radiant Research
Greer, South Carolina, 29651
Radiant Research
Mogadore, Ohio, 44260
Radiant Research
Scottsdale, Arizona, 85251
Radiant Research
St Louis, Missouri, 63141
About this study
Official title: A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP225 in Female Patients With Irritable Bowel Syndrome With Diarrhea
In this study, female patients with IBS-d will be treated for 8 weeks to assess the safety and effectiveness of DDP225 on GI transit and in reducing IBS symptoms.
Read the detailed description
This is a randomized, double-blind, placebo controlled, multicenter study designed to assess the safety and efficacy of DDP225 in patients with IBS-d. Female patients from 18 to 65 years of age with a history of IBS-d for at least 6 months are potentially eligible for entry into the study. A total of 88 eligible patients with IBS-d will be studied.
The total duration of study participation for an individual patient is approximately 10 weeks (74 days) from the initial screening visit to final study evaluations. The total duration of dosing with study medication (either DDP225 or placebo) is 8 weeks.
Patients who satisfy all of the inclusion criteria and none of the exclusion criteria are eligible to enter the Treatment Period and will be randomly assigned to one of four treatment groups.
After a patient is randomized and enters the Treatment Period, she will take the appropriate study medication once a day for 56 days and return to the clinic at two week intervals for a total of four visits during the Treatment Period. During the Treatment Period, patients will maintain a daily diary and complete questionnaires. One week after completing the 56-day Treatment Period, patients return to the clinic for final safety evaluations which include a physical examination, electrocardiogram, and clinical laboratory testing.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- DDP225
- Keywords
- IBS-d, IBS
- Medical subject headings
- Irritable Bowel Syndrome, Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDP225Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
GI Transit
Secondary outcomes (1)
Patient Reported Outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startSep 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynogen Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Patterson, MD, Study chair, Hotel Dieu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230581
- Sponsor's protocol ID
- DDP225-04-006
- Status last verified
- Oct 2007
- First submitted
- 29 Sep 2005
- Last updated
- 15 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP225 in Female Patients With Irritable Bowel Syndrome With Diarrhea
- ClinicalTrials.gov ID
- NCT00230581
- Acronym / sponsor ID
- DDP225-04-006
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS-d, IBS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Dynogen PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Aug 2007 (actual)
- First posted
- 3 Oct 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.
In this study, female patients with IBS-d will be treated for 8 weeks to assess the safety and effectiveness of DDP225 on GI transit and in reducing IBS symptoms.
Detailed description
This is a randomized, double-blind, placebo controlled, multicenter study designed to assess the safety and efficacy of DDP225 in patients with IBS-d. Female patients from 18 to 65 years of age with a history of IBS-d for at least 6 months are potentially eligible for entry into the study. A total of 88 eligible patients with IBS-d will be studied.
The total duration of study participation for an individual patient is approximately 10 weeks (74 days) from the initial screening visit to final study evaluations. The total duration of dosing with study medication (either DDP225 or placebo) is 8 weeks.
Patients who satisfy all of the inclusion criteria and none of the exclusion criteria are eligible to enter the Treatment Period and will be randomly assigned to one of four treatment groups.
After a patient is randomized and enters the Treatment Period, she will take the appropriate study medication once a day for 56 days and return to the clinic at two week intervals for a total of four visits during the Treatment Period. During the Treatment Period, patients will maintain a daily diary and complete questionnaires. One week after completing the 56-day Treatment Period, patients return to the clinic for final safety evaluations which include a physical examination, electrocardiogram, and clinical laboratory testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients from 18 to 65 years of age, inclusive.
- History of IBS-d for at least 6 months prior to the initial screening visit.
- Endoscopic/radiologic bowel evaluation to rule out cancer, obstruction, or other structural disease.
- The patient must have completed at least six days of assessments in the patient diary in the one week period prior to the second screening visit.
- Negative serum and urine pregnancy tests and post-partum for at least one year or not breast feeding at the initial screening visit and throughout the study. For patients able to bear children, an acceptable method of birth control must be used throughout the study. Patients unable to bear children must have documentation of such in the case report form (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
Key exclusion criteria (6 listed)
- Serious underlying diseases, including psychiatric disorders or current history of conditions affecting bowel transit including biochemical or structural abnormalities, or GI surgery
- Clinically significant abnormal examination findings or laboratory tests
- Inability to stop taking certain medications, or a planned change in medication (including herbal remedies) which could interfere with study assessments
- Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
- Presence of a medical condition which could interfere with the interpretation of study data
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 |
|---|---|---|
| DDP225 | Drug | – |
Primary outcome
GI Transit
1 secondary outcome
Patient Reported Outcomes
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 15 Oct 2007.
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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.
William Patterson, MD study chair
Hotel Dieu Hospital
16 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 DDP225 in people with Irritable Bowel Syndrome, run by Dynogen Pharmaceuticals at 16 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 6 inclusion and 6 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 15 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada, United States. 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 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?
GI Transit. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2007.