NSAID-induced Gastroduodenal InjuryPhase 2NCT00597818

Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

A Phase 2 study testing Cobiprostone and Non-steroidal anti-inflammatory drug in people with NSAID-induced Gastroduodenal Injury and Ulcers, run by Sucampo Pharma Americas, LLC at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to determine the efficacy and safety of three dose levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20 months. Read more about this study

Who is it for?: Ages 40 to 70 years
Conditions the study is for: NSAID-induced Gastroduodenal Injury, Ulcers, Rheumatoid Arthritis
What is being tested?: Cobiprostone and Non-steroidal anti-inflammatory drug
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 19 sitesUnited States
Study dates: Aug 2007to May 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is more than 40 and less than 70 years of age.
Patient has confirmed osteoarthritis (OA) and/or rheumatoid arthritis (RA) and could benefit from NSAID therapy.
No current gastrointestinal H. pylori infection.

Who cannot join

Known allergy or hypersensitivity to NSAIDs, or has any other contraindicated condition(s) to NSAID therapy.
Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
Medical history includes prior or active GI complications and/or disorders, including but not limited to Barrett's esophagus, erosive esophagitis, esophageal stricture or ring, gastric obstruction, irritable bowel syndrome (IBS), or inflammatory bowel disease (IBD).
Active symptomatic peptic ulcer disease or GI bleeding.
Patient has received cobiprostone (SPI-8811; RU-8811) or AMITIZA (other names: lubiprostone, SPI-0211, or RU-0211) at any time prior to participation in this study.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Gulf Coast Research, LLC
Baton Rouge, Louisiana, 70808
Boston Medical Center
Boston, Massachusetts, 02118
University of North Carolina Gastroenterology
Chapel Hill, North Carolina, 27599
University of Illinois Medical Center
Chicago, Illinois, 60612
Gregory J. Wiener, MD PC
Chula Vista, California, 91910
Dallas VA Research Corporation, Inc.
Dallas, Texas, 75216
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023
Houston Institute for Clinical Research
Houston, Texas, 77074
Loma Linda University Physicians Medical Group
Loma Linda, California, 92354
Facey Medical Foundation
Mission Hills, California, 91345
Research Associates of New York
New York, New York, 10021
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Oklahoma Founddation for Digestive Research
Oklahoma City, Oklahoma, 73104
Desert Oasis Healthcare
Palm Springs, California, 92262
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Gastroenterology Section at Temple University Hospital
Philadelphia, Pennsylvania, 19140
Carl T Hayden VA Medical Center
Phoenix, Arizona, 85012
Sepulveda Ambulatory Care Center
Sepulveda, California, 91343

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone for the Prevention of NSAID-induced Gastroduodenal Injury in Patients With Osteoarthritis and/or Rheumatoid Arthritis Patients

The primary purpose of this study is to determine the efficacy and safety of three dose levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20 months.

Conditions: NSAID-induced Gastroduodenal Injury, Ulcers, Rheumatoid Arthritis, Osteoarthritis
Being tested: Cobiprostone, Placebo, Non-steroidal anti-inflammatory drug
Medical subject headings: Ulcer, Arthritis, Rheumatoid, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CobiprostoneDrug
Also called SPI-8811, RU-8811
18 mcg cobiprostone capsules for oral administration
PlaceboDrug
Also called Matching Placebo
Matching placebo capsules for oral administration
Non-steroidal anti-inflammatory drugDrug
Also called Standard Care
Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.

Study groups in NCT00597818
Study group	Role	What they receive
Placebo	Placebo comparator	Participants receive matching placebo capsules for 20 months Receives: Drug: Placebo; Drug: Non-steroidal anti-inflammatory drug
Cobiprostone QD	Experimental	Participants receive 18 mcg cobiprostone once daily (QD) for 20 months Receives: Drug: Cobiprostone; Drug: Non-steroidal anti-inflammatory drug
Cobiprostone BID	Experimental	Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months Receives: Drug: Cobiprostone; Drug: Non-steroidal anti-inflammatory drug
Cobiprostone TID	Experimental	Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months Receives: Drug: Cobiprostone; Drug: Non-steroidal anti-inflammatory drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Gastric Ulcers
Measured: at 20 months

Secondary outcomes (3)

Number of Participants With Duodenal and Gastroduodenal Ulcers
Measured: at 20 months
Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers
Measured: at Week 4
Size of Ulcers/Erosions
Measured: at 20 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007May 2009

First posted18 Jan 2008 (estimated)
Study startAug 2007
Primary completionApr 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NSAID-induced Gastroduodenal InjuryStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00597818
Sponsor's protocol ID: SU0621
Status last verified: Mar 2018
First submitted: 10 Jan 2008
Last updated: 26 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone for the Prevention of NSAID-induced Gastroduodenal Injury in Patients With Osteoarthritis and/or Rheumatoid Arthritis Patients
ClinicalTrials.gov ID: NCT00597818
Acronym / sponsor ID: SU0621
Conditions: NSAID-induced Gastroduodenal Injury, Ulcers, Rheumatoid Arthritis, Osteoarthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Sucampo Pharma Americas, LLCIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Apr 2009 (actual)
Study completion: May 2009 (actual)
First posted: 18 Jan 2008 (estimated)
Results: Posted 26 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this study is to determine the efficacy and safety of three dose levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo, Drug: Non-steroidal anti-inflammatory drugParticipants receive matching placebo capsules for 20 months
Cobiprostone QD	Experimental	Drug: Cobiprostone, Drug: Non-steroidal anti-inflammatory drugParticipants receive 18 mcg cobiprostone once daily (QD) for 20 months
Cobiprostone BID	Experimental	Drug: Cobiprostone, Drug: Non-steroidal anti-inflammatory drugParticipants receive 18 mcg cobiprostone twice daily (BID) for 20 months
Cobiprostone TID	Experimental	Drug: Cobiprostone, Drug: Non-steroidal anti-inflammatory drugParticipants receive 18 mcg cobiprostone three times daily (TID) for 20 months

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient is more than 40 and less than 70 years of age.
Patient has confirmed osteoarthritis (OA) and/or rheumatoid arthritis (RA) and could benefit from NSAID therapy.
No current gastrointestinal H. pylori infection.

Key exclusion criteria (5 listed)

Known allergy or hypersensitivity to NSAIDs, or has any other contraindicated condition(s) to NSAID therapy.
Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
Medical history includes prior or active GI complications and/or disorders, including but not limited to Barrett's esophagus, erosive esophagitis, esophageal stricture or ring, gastric obstruction, irritable bowel syndrome (IBS), or inflammatory bowel disease (IBD).
Active symptomatic peptic ulcer disease or GI bleeding.
Patient has received cobiprostone (SPI-8811; RU-8811) or AMITIZA (other names: lubiprostone, SPI-0211, or RU-0211) at any time prior to participation in this study.

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
CobiprostoneAlso: SPI-8811, RU-881118 mcg cobiprostone capsules for oral administration	Drug	Cobiprostone BID, Cobiprostone QD, Cobiprostone TID
PlaceboAlso: Matching PlaceboMatching placebo capsules for oral administration	Drug	Placebo
Non-steroidal anti-inflammatory drugAlso: Standard CareAny marketed non-steroidal anti-inflammatory drug used by the participants as standard care.	Drug	Cobiprostone BID, Cobiprostone QD, Cobiprostone TID, Placebo

Primary outcome

Number of Participants With Gastric Ulcers
Time frame: at 20 months

3 secondary outcomes

Number of Participants With Duodenal and Gastroduodenal Ulcers
Time frame: at 20 months
Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers
Time frame: at Week 4
Size of Ulcers/Erosions
Time frame: at 20 Months

Results and safety

Results posted to the registry on 26 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	30	12
18 mcg	30	14
36 mcg	31	12
54 mcg	30	20

Primary outcome: Number of Participants With Gastric Ulcers

Time frame: at 20 months. Count of participants. Unit: Participants

Measure	Placebo n = 30	Cobiprostone QD n = 30	Cobiprostone BID n = 31	Cobiprostone TID n = 30
Value	7	5	7	4

Population analysed: Intention to treat (ITT) population, defined as all participants enrolled in the trial

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All participants were treated and followed for ulcers and other adverse events for a total of 20 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	22 of 30 (73.3%)	20 of 30 (66.7%)	Not reported
Cobiprostone QD	23 of 30 (76.7%)	18 of 30 (60%)	Not reported
Cobiprostone BID	25 of 31 (80.6%)	22 of 31 (71%)	Not reported
Cobiprostone TID	26 of 30 (86.7%)	21 of 30 (70%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Global Clinical Leader study director

Mallinckrodt

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 26 Dec 2019. 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. 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?

Yes. Results are posted in the registry (first posted 26 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Gastric Ulcers (time frame: at 20 months). 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 NCT00597818.

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 26 Dec 2019.