Chronic Idiopathic ConstipationPhase 3NCT01372423
Evaluation of Clinical Equivalence Between Two Lubiprostone Products
A Phase 3 study testing Lubiprostone in people with Chronic Idiopathic Constipation, run by Anchen Pharmaceuticals, Inc at 79 sites in United States.
Trial summary
The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of lubiprostone 24 mcg capsules compared to the marketed formulation AMITIZA® (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed chronic idiopathic constipation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Idiopathic Constipation
- What is being tested?
- Lubiprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 808 participants
- Where
- 79 sitesUnited States
- Study dates
- May 2011to Jun 2012
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- 1. Male or non-pregnant females aged 18 and older with a clinical diagnosis of chronic idiopathic constipation defined as, on average, < 3 spontaneous bowel movements (SBMs) per week for the past 6 months and confirmed by daily diary during the 14 day baseline lead-in period. An SBM is defined as any bowel movement that did not occur within 24 hours after rescue medication use.
- Have 1 or more of the following symptoms related to bowel movements for at least 6 months before the baseline visit and confirmed by daily diary during the 14 Day baseline period:
- very hard (little balls) and/or hard stools for at least 25 percent of the bowel movements
- sensation of incomplete evacuation following at least 25 percent of the bowel movements
- straining at defecation at least a quarter of the time
- Women of child-bearing potential must have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.
- For patients aged < 50 years, documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within the 5 years prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large Bowel.
- For patients aged >/= 50 years, documentation of the results of either a barium enema with flexible sigmoidoscopy or colonoscopy performed within 1 year prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large bowel.
Main Exclusion Criteria:
- Females who are Pregnant, breast feeding, or planning a pregnancy.
- Patients of any age with evidence of weight loss, anemia, or rectal bleeding AND without documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed during the 6 months prior to dosing.
- Patients that have documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction.
- Any known or suspected organic disorders of the large or small bowel (e.g., inflammatory bowel disease, ulcerative colitis, Crohn's Disease) or constipation secondary to a documented cause (e.g., surgery, bowel resection)or acute hernia.
- History of bowel resection.
- Patients who are regularly using medications know to cause constipation (narcotics, calcium channel blockers, tricyclic antidepressants).
- Hospitalized for any gastrointestinal or abdominal surgical procedure during the 3 months prior to dosing.
- Clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities.
- Use of a systemic antibiotic within 4 weeks prior to the Screening Visit.
- Participation in a study with any investigational medication within the past 30 days of screening for this study or previous participation in this study.
Trial locations and contacts
79 sites in 1 country.
79 sites in 1 country
United States79 sites
Novum Investigator Site
Adventura, Florida
Novum Investigator Site
Beavercreek, Ohio
Novum Investigator Site
Billings, Montana
Novum Investigator Site
Boyton Beach, Florida
Novum Investigator Site
Bradenton, Florida
Novum Investigator Site
Brookville, Florida
Novum Investigator Site
Buena Park, California
Novum Investigator Site
Cary, North Carolina
Novum Investigator Site
Centerville, Ohio
Novum Investigator Site
Chandler, Arizona
Novum Investigator Site
Charlotte, North Carolina
Novum Investigator Site
Charlottesville, Virginia
Novum Investigator Site
Chattanooga, Tennessee
Novum Investigator Site
Clearwater, Florida
Novum Investigator Site
Columbia, South Carolina
Novum Investigator Site
Decauter, Georgia
Novum Investigator Site
Deerfield Beach, Florida
Novum Investigator Site
Denver, Colorado
Novum Investigator Site
Dothan, Alabama
Novum Investigator Site
Evansville, Indiana
Novum Investigator Site
Fresno, California
Novum Investigator Site
Garden Grove, California
Novum Investigator Site
Germantown, Tennessee
Novum Investigator Site
Gilbert, Arizona
Novum Investigator Site
Henderson, Nevada
Novum Investigator Site
Hermitage, Tennessee
Novum Investigator Site
High Point, North Carolina
Novum Invesitgator Site
Hollywood, Maryland
Novum Investigator Site
Hot Springs, Arkansas
Novum Investigator Site
Houston, Texas
Novum Investigator Site
Huntsville, Alabama
Novum Investigator Site
Jackson, Mississippi
Novum Investigator Site
Jupiter, Florida
Novum Investigator Site
La Palma, California
Novum Investigator Site
Lewiston, Idaho
Novum Investigator Site
Lexington, Kentucky
Novum Investigator Site
Lincoln, Nebraska
Novum Investigator Site
Little Rock, Arkansas
Novum Investigator Site
Long Beach, California
Novum Investigator Site
Longview, Texas
Novum Investigator Site
Maimi, Florida
Novum Investigator Site
Marlton, New Jersey
Novum Investigator Site
Mesa, Arizona
Novum Investigator Site
Mexico, Missouri
Novum Investigator Site
Miami, Florida
Novum Investigator Site
Mobile, Alabama
Novum Investigator Site
Mountain Home, Arkansas
Novum Investigator Site
Mountain Lake, Washington
Novum Investigator Site
Newport News, New Jersey
Novum Investigator Site
Niceville, Florida
Novum Investigator Site
Ormond Beach, Florida
Novum Investigator Site
Panama City, Florida
Novum Investigator Site
Phoenix, Arizona
Novum Investigator Site
Phoeniz, Arizona
Novum Investigator Site
Port Orange, Florida
Novum Investigator Site
Poughkeepsie, New York
Novum Investigator Site
Raleigh, North Carolina
Novum Investigator Site
Rockford, Illinois
Novum Investigator Site
Sacremento, California
Novum Investigator Site
Salisbury, North Carolina
Novum Investigator Site
San Antonio, Texas
Novum Investigator Site
San Diego, California
Novum Invesitgator Site
San Ramon, California
Novum Investigator Site
Sandy Springs, Georgia
Novum Investigator Site
Santa Ana, California
Novum Investigator Site
Sherwood, Arkansas
Novum Investigator Site
Shreveport, Louisiana
Novum Investigator Site
St. Petersburg, Florida
Novum Investigator Site
Stockbridge, Georgia
Novum Investigator Site
Sugarland, Texas
Novum Investigator Site
Sylvania, Ohio
Novum Investigator Site
Tampa, Florida
Novum Investigator Site
Virginia Beach, Virginia
Novum Investigator Site
Washington, Missouri
Novum Investigator Site
West Palm Beach, Florida
Novum Investigator Site
Westlake Village, California
Novum Investigator Site
Wheat Ridge, Colorado
Novum Investigator Site
Wilmington, North Carolina
Novum Investigator Site
Winstom-Salem, North Carolina
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Lubiprostone 24 Mcg Capsules (Anchen Pharmaceuticals, Inc.) With AMITIZA® (Lubiprostone) 24 Mcg Capsules (Sucampo Pharmaceuticals, Inc.) in the Treatment of Chronic Idiopathic Constipation
The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of lubiprostone 24 mcg capsules compared to the marketed formulation AMITIZA® (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed chronic idiopathic constipation.
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- Lubiprostone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubiprostoneDrug
24 mcg capsules
PlaceboDrug
24 mcg capsules
| Study group | Role | What they receive |
|---|---|---|
| AMITIZA | Active comparator | Manufactured by Sucampo Pharmaceuticals (24 mcg administered for 7 days) Receives: Drug: Lubiprostone |
| Placebo | Placebo comparator | Manufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days) Receives: Drug: Placebo |
| Lubiprostone | Experimental | Manufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days) Receives: Drug: Lubiprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Analysis
Clinical equivalence of the Test and Reference treatments and the superiority of each active treatment over the Placebo in the change from baseline in mean number of SBM's during the 7 day randomization period of the study.
Measured: Day 8
Secondary outcomes (1)
Safety Analysis
The frequency and severity of adverse events across treatment groups will be analyzed.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 808 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anchen Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372423
- Sponsor's protocol ID
- CS-01-2011
- Other IDs
- 71060001
- Status last verified
- Jul 2012
- First submitted
- 10 Jun 2011
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Lubiprostone 24 Mcg Capsules (Anchen Pharmaceuticals, Inc.) With AMITIZA® (Lubiprostone) 24 Mcg Capsules (Sucampo Pharmaceuticals, Inc.) in the Treatment of Chronic Idiopathic Constipation
- ClinicalTrials.gov ID
- NCT01372423
- Acronym / sponsor ID
- CS-01-2011
- Conditions
- Chronic Idiopathic Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 808 participants (actual)
- Lead sponsor
- Anchen Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Jun 2011 (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.
The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of lubiprostone 24 mcg capsules compared to the marketed formulation AMITIZA® (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed chronic idiopathic constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMITIZA | Active comparator | Drug: LubiprostoneManufactured by Sucampo Pharmaceuticals (24 mcg administered for 7 days) |
| Placebo | Placebo comparator | Drug: PlaceboManufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days) |
| Lubiprostone | Experimental | Drug: LubiprostoneManufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Lubiprostone24 mcg capsules | Drug | AMITIZA, Lubiprostone |
| Placebo24 mcg capsules | Drug | Placebo |
Primary outcome
Primary Analysis
Time frame: Day 8
Clinical equivalence of the Test and Reference treatments and the superiority of each active treatment over the Placebo in the change from baseline in mean number of SBM's during the 7 day randomization period of the study.
1 secondary outcome
Safety Analysis
Time frame: Day 8
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 12 Jul 2012.
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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.
79 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lubiprostone in people with Chronic Idiopathic Constipation, run by Anchen Pharmaceuticals, Inc at 79 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?
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 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 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 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.
What does the primary outcome measure?
Primary Analysis (time frame: Day 8). 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 12 Jul 2012.