Crohn's DiseasePhase 2NCT00101946
Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease
A Phase 2 study testing 683699 in people with Crohn's Disease, run by GlaxoSmithKline at 19 sites in 2 countries.
Trial summary
This study will evaluate the effectiveness and safety of the investigational drug 683699 in treating subjects with moderately to severely active CD (Crohn's Disease). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- 683699
- How many people
- 17 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Oct 2004to Jul 2006
- 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
- Diagnosed with CD and reconfirmed in previous 2 years by a radiologic or endoscopic assessment including histology.
- CDAI (Crohn's Disease Activity Index) score of 220-450 after 1 week of screening.
- CRP (C-Reactive Protein) level of >4mg at screening.
Who cannot join
- Significantly abnormal laboratory tests or ECG (electrocardiogram) results.
- Current use of an elemental diet or parenteral nutrition.
- Clinically significant positive stool culture.
- Ongoing neoplastic disease of the bowel.
- Bowel perforation other than fistulae.
- Has an ileostomy or colostomy.
Show all 21Show fewer
- Fixed symptomatic gastrointestinal (GI) stricture within 6 months or obstructive symptoms within 3 months of screening.
- Any bowel resection within 12 months of screening or bowel resection without subsequent demonstration of recurrence of active CD.
- More than 100cm of bowel resected.
- Non-curative bowel surgery with 2 months of screening.
- Symptoms attributed to short bowel syndrome.
- Uncontrolled bacterial, viral, or fungal infection or congenital or acquired immunodeficiency.
- Women who are pregnant, breast feeding, or planning to become pregnant during the study.
- Permitted medications:
- Less than or equal to 20mg/day oral corticosteroids for at least 4 weeks prior to screening and on stable doses for 2 weeks prior to screening.
- Azathioprine and 6-MP (6-Mercaptopurine) stable dose for 3 months prior to screening.
- 5-ASA (5-Aminosalicylic acid) stable dose for 1 month prior to screening.
- Prohibited medications:
- Greater than 20mg/day oral corticosteroids, or systemic intravenous corticosteroids, or antibiotics as a treatment for CD within 4 weeks prior to screening.
- Cyclosporine or methotrexate during the 2 months prior to screening.
- Infliximab or other biological treatments within 3 months prior to screening.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States13 sites
GSK Investigational Site
Charlotte, North Carolina, 28211
GSK Investigational Site
Cincinnati, Ohio, 45219
GSK Investigational Site
Garden Grove, California, 92840
GSK Investigational Site
Great Neck, New York, 11021
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Memphis, Tennessee, 38120
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
Simpsonville, South Carolina, 29681
GSK Investigational Site
Topeka, Kansas, 66614
GSK Investigational Site
West Yarmouth, Massachusetts, 02673
Canada6 sites
GSK Investigational Site
Calgary, Alberta, T2N 4N1
GSK Investigational Site
Lévis, Quebec, G6V 3Z1
GSK Investigational Site
Québec, Quebec, G1S 4L8
GSK Investigational Site
Saskatoon, Saskatchewan, S7K 1J5
GSK Investigational Site
Toronto, Ontario, M3N 2V7
GSK Investigational Site
Windsor, Ontario, N8X 5A6
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Nine-weeks Administration of Three Doses of SB-683699 in Subjects With Moderately to Severely Active Crohn's Disease
This study will evaluate the effectiveness and safety of the investigational drug 683699 in treating subjects with moderately to severely active CD (Crohn's Disease).
- Conditions
- Crohn's Disease
- Being tested
- 683699
- Keywords
- CD, Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
683699Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who are responders at Week 6.
Secondary outcomes (1)
- Proportion of subjects with response at other timepoints. - Proportion of subjects in remission. - Average rate of response for the CDAI score. - Mean change from baseline in CDAI score Improvement in 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 posted19 Jan 2005 (estimated)
- Study startOct 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101946
- Sponsor's protocol ID
- 683699/004
- Status last verified
- Apr 2015
- First submitted
- 18 Jan 2005
- Last updated
- 13 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Nine-weeks Administration of Three Doses of SB-683699 in Subjects With Moderately to Severely Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT00101946
- Acronym / sponsor ID
- 683699/004
- Conditions
- Crohn's Disease
- Keywords
- CD, Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 19 Jan 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 effectiveness and safety of the investigational drug 683699 in treating subjects with moderately to severely active CD (Crohn's Disease).
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 (3 listed)
- Diagnosed with CD and reconfirmed in previous 2 years by a radiologic or endoscopic assessment including histology.
- CDAI (Crohn's Disease Activity Index) score of 220-450 after 1 week of screening.
- CRP (C-Reactive Protein) level of >4mg at screening.
Key exclusion criteria (21 listed)
- Significantly abnormal laboratory tests or ECG (electrocardiogram) results.
- Current use of an elemental diet or parenteral nutrition.
- Clinically significant positive stool culture.
- Ongoing neoplastic disease of the bowel.
- Bowel perforation other than fistulae.
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 |
|---|---|---|
| 683699 | Drug | – |
Primary outcome
Proportion of subjects who are responders at Week 6.
1 secondary outcome
- Proportion of subjects with response at other timepoints. - Proportion of subjects in remission. - Average rate of response for the CDAI score. - Mean change from baseline in CDAI score Improvement in 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 13 Apr 2015.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
19 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 683699 in people with Crohn's Disease, run by GlaxoSmithKline at 19 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 3 inclusion and 21 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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. 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?
Proportion of subjects who are responders at Week 6.. 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 13 Apr 2015.