Ulcerative ColitisPhase 2/3NCT00033943
Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis
A Phase 2/3 study testing deligoparin in people with Ulcerative Colitis, run by Incara Pharmaceuticals at 33 sites in United States.
Trial summary
This study will evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- deligoparin
- How many people
- 270 participants
- Where
- 33 sitesUnited States
- Study dates
- Jan 2001to Sep 2002
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of ulcerative colitis at least 3 months with biopsy and colonoscopy confirmation.
- Treatment with aminosalicylates at least 28 days, if tolerated.
- Duration of current flare-up at least 7 days.
- Must be able to self administer once-daily subcutaneous (under the skin) injections of study drug.
Who cannot join
- Disease limited to the rectum.
- Toxic megacolon.
- The use of anticoagulant drugs.
- A history of any bleeding disorder.
- A history of heparin-induced thrombocytopenia.
- Evidence of liver or kidney impairment.
- Women who are pregnant or breast feeding.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
AGMG Clinical Research
Anaheim, California, 92801
University of Michigan Health System
Ann Arbor, Michigan, 48109
Atlanta Gastroenterology Associates, LLC
Atlanta, Georgia, 30342
Univ. of North Carolina Hospital
Chapel Hill, North Carolina, 27599
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 28207
Univ. of Virginia Health System
Charlottesville, Virginia, 22908
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke Health Center
Durham, North Carolina, 27710
GANT Research, PA
Fort Worth, Texas, 76102
University of Florida Gainesville/Gainesville VAMC
Gainesville, Florida, 32608
Long Island Clinical Research Associates
Great Neck, New York, 11021
Borland-Groover Clinic
Jacksonville, Florida, 32223
Rocky Mountain Gastroenterology Associates
Lakewood, Colorado, 80215
Univ. of Kentucky Medical Center
Lexington, Kentucky, 40536
Gastroenterology Specialties, PC
Lincoln, Nebraska, 68503
Rocky Mountain Clinical Research
Littleton, Colorado, 80120
Memphis Gastroenterology Group, PC
Memphis, Tennessee, 38120
University of Miami, Division of Clinical Pharmacology
Miami, Florida, 33136
Miami Research Associates
Miami, Florida, 33173
Wisconsin Center for Advanced Research, LLC
Milwaukee, Wisconsin, 53207
Nashville Clinical Research
Nashville, Tennessee, 37211
Daniel H. Present, MD
New York, New York, 10028
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
Community Clinical Trials
Orange, California, 92868
Hospital of the Univ. of Pennsylvania
Philadelphia, Pennsylvania, 19104
West Hills Gastroenterology
Portland, Oregon, 97225
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Minnesota Clinical Research Center
Saint Paul, Minnesota, 55114
Gastroenterology Clinic of San Antonio
San Antonio, Texas, 78229
Washington Univ. School of Medicine
St Louis, Missouri, 63110
Gastroenterology United of Tulsa
Tulsa, Oklahoma, 74135
About this study
Official title: A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Two Dosage Levels of OP2000 (75 Mg and 125 Mg) Administered Once Daily by Subcutaneous Injection for the Treatment of Active Ulcerative Colitis
This study will evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis.
Read the detailed description
This is a double-blind, placebo-controlled, research study to evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis. Patients will be randomized (assigned by chance like the toss of a coin) to receive 75 mg OP2000, 125 mg OP2000, or placebo once daily for 6 weeks. Study drug will be administered by subcutaneous (under the skin) injection and patients will be taught how to self-administer these injections. Following an initial Screening Visit, eligible patients will return to the clinic for initiation of study treatment and then again for follow-up visits after 1, 2, 4 and 6 weeks of treatment. A follow-up telephone call will be scheduled 2 months (and possibly also 4 and 6 months) after completing study treatment. Study procedures will include a flexible sigmoidoscopy at the Screening Visit and at the Week 6 visit.
- Conditions
- Ulcerative Colitis
- Being tested
- deligoparin
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deligoparinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2002 (estimated)
- Study startJan 2001
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 270 participants
Sponsor and investigators
- Lead sponsor
- Incara Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033943
- Sponsor's protocol ID
- OP201
- Status last verified
- Oct 2002
- First submitted
- 16 Apr 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Two Dosage Levels of OP2000 (75 Mg and 125 Mg) Administered Once Daily by Subcutaneous Injection for the Treatment of Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00033943
- Acronym / sponsor ID
- OP201
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants
- Lead sponsor
- Incara PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- Sep 2002
- First posted
- 17 Apr 2002 (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 experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis.
Detailed description
This is a double-blind, placebo-controlled, research study to evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis. Patients will be randomized (assigned by chance like the toss of a coin) to receive 75 mg OP2000, 125 mg OP2000, or placebo once daily for 6 weeks. Study drug will be administered by subcutaneous (under the skin) injection and patients will be taught how to self-administer these injections. Following an initial Screening Visit, eligible patients will return to the clinic for initiation of study treatment and then again for follow-up visits after 1, 2, 4 and 6 weeks of treatment. A follow-up telephone call will be scheduled 2 months (and possibly also 4 and 6 months) after completing study treatment. Study procedures will include a flexible sigmoidoscopy at the Screening Visit and at the Week 6 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of ulcerative colitis at least 3 months with biopsy and colonoscopy confirmation.
- Treatment with aminosalicylates at least 28 days, if tolerated.
- Duration of current flare-up at least 7 days.
- Must be able to self administer once-daily subcutaneous (under the skin) injections of study drug.
Key exclusion criteria (7 listed)
- Disease limited to the rectum.
- Toxic megacolon.
- The use of anticoagulant drugs.
- A history of any bleeding disorder.
- A history of heparin-induced thrombocytopenia.
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 |
|---|---|---|
| deligoparin | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing deligoparin in people with Ulcerative Colitis, run by Incara Pharmaceuticals at 33 sites in United States.
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 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in 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 combined 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.
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.
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 24 Jun 2005.