Irritable Bowel Syndrome With ConstipationPhase 2NCT00215566
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c
A Phase 2 study testing DDP733 in people with Irritable Bowel Syndrome With Constipation and Irritable Bowel Syndrome, run by Dynogen Pharmaceuticals at 15 sites in Canada.
Trial summary
This study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome
- What is being tested?
- DDP733
- How many people
- 90 participants
- Where
- 15 sitesCanada
- Study dates
- Sep 2005to not given
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a history of IBS-c for at least 3 months prior to randomization as assessed using ROME criteria
- Must have had endoscopic/radiologic bowel evaluation within the past 10 years
- Must comply with completing a daily diary and be able to comply with GI transit measurements, including swallowing capsules containing small x-ray visible markers
- Female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding
Who cannot join
- Serious underlying diseases, including psychiatric disorders
- Current history of conditions affecting bowel transit
- Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection
- Clinically significant abnormal examination findings or laboratory tests
- Inability to stop taking certain medications, or a planned change in medications (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
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Hys Medical Centre
Edmonton, Alberta, T5H 4B9
Surrey GI Clinic
Guelph, Ontario
QE II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
St. Joseph's Healthcare
London, Ontario, N6A 4V2
Meadowlands Family Health Centre
Ottawa, Ontario
Hopital St-Sacrement
Québec, Quebec, G1S 4L8
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, M3N 2V7
St Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Study site
West Vancouver, British Columbia
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP733 in Patients With Irritable Bowel Syndrome With Constipation
This study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.
- Being tested
- DDP733
- Keywords
- IBS, IBS-c
- 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.
DDP733Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of DDP733 on gastrointestinal transit
Secondary outcomes (1)
Evaluation of the effect of DDP733 on 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 posted22 Sep 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With ConstipationStudies 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
- 90 participants
Sponsor and investigators
- Lead sponsor
- Dynogen Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Paterson, MD, Study chair, Hotel Dieu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215566
- Sponsor's protocol ID
- DDP733-04-007
- Status last verified
- Mar 2006
- First submitted
- 19 Sep 2005
- Last updated
- 28 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP733 in Patients With Irritable Bowel Syndrome With Constipation
- ClinicalTrials.gov ID
- NCT00215566
- Acronym / sponsor ID
- DDP733-04-007
- Keywords
- IBS, IBS-c
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Dynogen PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- 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.
This study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have a history of IBS-c for at least 3 months prior to randomization as assessed using ROME criteria
- Must have had endoscopic/radiologic bowel evaluation within the past 10 years
- Must comply with completing a daily diary and be able to comply with GI transit measurements, including swallowing capsules containing small x-ray visible markers
- Female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding
Key exclusion criteria (8 listed)
- Serious underlying diseases, including psychiatric disorders
- Current history of conditions affecting bowel transit
- Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection
- Clinically significant abnormal examination findings or laboratory tests
- Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments
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 |
|---|---|---|
| DDP733 | Drug | – |
Primary outcome
Evaluation of the effect of DDP733 on gastrointestinal transit
1 secondary outcome
Evaluation of the effect of DDP733 on 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 28 May 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 Paterson, MD study chair
Hotel Dieu Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DDP733 in people with Irritable Bowel Syndrome With Constipation and Irritable Bowel Syndrome, run by Dynogen Pharmaceuticals at 15 sites in Canada.
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 4 inclusion and 8 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 28 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in 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. 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?
Evaluation of the effect of DDP733 on gastrointestinal 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 28 May 2007.