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Chronic Idiopathic ConstipationPhase 3NCT01674530

Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation

A Phase 3 study testing Lubiprostone in people with Chronic Idiopathic Constipation, run by Dr. Reddy's Laboratories Limited at 93 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 objective of this study is to evaluate the clinical equivalence and safety of the test formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed… 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
909 participants
Where
93 sitesUnited States
Study dates
Oct 2012to Mar 2014
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. Patients who have signed the written informed consent form prior to entering the study.
  2. Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of CIC defined as, on average, < 3 SBMs per week and confirmed by daily diary during the two week baseline/washout period. An SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use.
  3. Patients with body mass index between 18 and 35kg/m2 (both inclusive)
  4. Have one or more of the following symptoms related to BMs for at least 6 months before the baseline visit and confirmed by daily diary during the 2 weeks baseline/washout period:
  5. very hard (little balls) and/or hard stools for at least 25% of the bowel movements ii. sensation of incomplete evacuation following at least 25% of the bowel movements iii. straining at defecation at least a quarter of the time
  6. Women of child-bearing potential should have a negative serum pregnancy test prior to beginning therapy and agree to use effective contraceptive methods (at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal IUDs, sexual abstinence or vasectomy of the partner) during the study.
  7. For patients aged < 50 years, documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within the five years prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large or small bowel.
  8. For patients aged ≥ 50 years, documentation of the results of either a barium enema with flexible sigmoidoscopy or colonoscopy performed within one year prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large or small bowel.

Main Exclusion Criteria:

  1. Females who are pregnant, breast feeding, or planning a pregnancy during the proposed study period.
  2. 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.
  3. Patients who have documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction.
  4. Patients with 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 or with neurologic diseases or other diseases that cause motility problems for example Parkinson's disease and spinal cord injury, etc.
  5. Patients with a history of bowel resection.
  6. Patients who are regularly using medications, which are known to cause constipation (anticholinergics, narcotics, calcium channel blockers, tricyclic antidepressants, colchicine, iron supplements, magnesium supplements).
  7. Patients who are hospitalized for any gastrointestinal or abdominal surgical procedure during the three months prior to dosing.
  8. Patients with clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities (if laboratory values exceed 2X Upper Limit of Normal the approval of medical monitor should be taken into consideration before randomizing the patient).
  9. Use of systemic antibiotics within four weeks prior to baseline.
  10. Any current or planned significant change in diet during the study.
  11. Participation in a study with any investigational medication within the past 30 days before screening for this study or previous participation in this study.

Trial locations and contacts

93 sites in 1 country.

93 sites in 1 country

United States93 sites

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • Mount Vernon Clinical Research

    Atlanta, Georgia, 30328

  • Gastroenterology Consultants PC

    Atlanta, Georgia, 30342

  • Radiant Research

    Birmingham, Alabama, 35209

  • Boston Clinical Trials Inc

    Boston, Massachusetts, 2131

  • Consultants of Clinical

    Boynton Beach, Florida, 33426

  • PAB Clinical Research

    Brandon, Florida, 33511

  • Beacon Clinical Research

    Brockton, Massachusetts, 02301

  • Hosc Inc.

    Brooklyn, New York, 11206

  • Valley Medical Research

    Centerville, Ohio, 45459

  • Charlottesville Medical Research Center

    Charlottesville, Virginia, 22911

  • Clinsearch LLC

    Chattanooga, Tennessee, 37421

  • Clinical Research Institute

    Chesterfield, Michigan, 48047

  • Elite Trials

    Clearwater, Florida, 33761

  • Rapid Medical Research , Inc

    Cleveland, Ohio, 44122

  • Radiant Research

    Columbus, Ohio, 43212

  • KRK Medical Research

    Dallas, Texas, 75230

  • Horizons Clinical Research Center

    Denver, Colorado, 80220

  • Radiant Research

    Denver, Colorado, 80239

  • Lynn Institute of Denver

    Denver, Colorado, 80246

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Central Jersey Medical Research Center

    Elizabeth, New Jersey, 07202

  • Diagnamics Inc,477 N. El Camino Real,Suite A100

    Encinitas, California, 92024

  • Advanced Medical Research Institute

    Fresno, California, 93710

  • Research Center of Fresno

    Fresno, California, 93726

  • Radiant Research

    Greer, South Carolina, 29650

  • Health Care Family Rehabilitation and Research Center

    Hialeah, Florida, 33012

  • Medical Research Unlimited, LLC

    Hialeah, Florida, 33012

  • Peters Medical Research

    High Point, North Carolina, 27262

  • NY Scientific,189-11 Jamaica Ave

    Hollis, New York, 11423

  • Gastroenterology Consultants P.A

    Houston, Texas, 77034

  • Clinical Trial Network

    Houston, Texas, 77074

  • Clinical Research Associates

    Huntsville, Alabama, 35801

  • GI Associates and Endoscopy Center

    Jackson, Mississippi, 39202

  • HCCA-CRS

    Jackson, Tennessee, 38305

  • Health Awareness ,Inc

    Jupiter, Florida, 33458

  • Bayer Research

    Kalamazoo, Michigan, 49009

  • Detweiler Family Medicine and Associates, PC

    Lansdale, Pennsylvania, 19446

  • Sunrise Medical Research

    Lauderdale Lakes, Florida, 33319

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • BlueRidge Medical Research

    Lynchburg, Virginia, 24502

  • Atlanta Gastroenterology Assoc

    Marietta, Georgia, 30067

  • Great Lakes Gastroenterology

    Mentor, Ohio, 44060

  • East Jefferson Gastro

    Metairie, Louisiana, 70006

  • San Marcus Research Clinic

    Miami, Florida, 33015

  • Pharmax Research Clinic

    Miami, Florida, 33126

  • Community Research Foundation , Inc.

    Miami, Florida, 33155

  • Florida International Research

    Miami, Florida, 33166

  • Columbus Clinical Services

    Miami, Florida, 33174

  • South Medical Research Group , Inc

    Miami, Florida, 33186

  • Drug Research Group, LLC

    Mobile, Alabama, 36608

  • Pharma Research International, Inc

    Naples, Florida, 34109

  • Pharma Research International, Inc

    Naples, Florida, 34110

  • University Hospital,150 Bergen Street,B-134 Pharmacy

    Newark, New Jersey, 07103

  • Health Research of Hampton Roads

    Newport News, Virginia, 23606

  • Heartland Research Associates

    Newton, Kansas, 67114

  • Translational Research Group

    North Hollywood, California, 91606

  • Staywell Research

    Northridge, California, v

  • Quality Clinical Research, Inc

    Omaha, Nebraska, 68114

  • Elias Research Associates

    Orange, California, 92868

  • Compass Research

    Orlando, Florida, 32806

  • Ormond Medical Arts Pharmaceutical

    Ormond Beach, Florida, 32174

  • Research Integrity

    Owensboro, Kentucky, 42303

  • Digestive Health Center

    Pasadena, Texas, 77505

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania, 15206

  • Clinical Research of Central Florida

    Plant City, Florida, 33563

  • Accord Clinical Research,LLC

    Port Orange, Florida, 32129

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Benchmark Research

    Sacramento, California, 95816

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Paragon Research Center

    San Antonio, Texas, 78205

  • Quality Research, Inc

    San Antonio, Texas, 78209

  • Sun Research

    San Antonio, Texas, 78215

  • Texas Medical Research Associates , LLC

    San Antonio, Texas, 78238

  • Medical Center for CR

    San Diego, California, 92108

  • Shawn K Hassler

    San Francisco, California

  • Radiant Research

    Scottsdale, Arizona, 85251

  • Meridian Research

    St. Petersburg, Florida, 33709

  • Advanced Digestive Care Center , PC

    Stockbridge, Georgia, 30281

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Breco Research

    Sugarland, Texas, 77479

  • Pioneer Research Solutions , Inc

    Sugarland, Texas, 77479

  • Meridian Research

    Tampa, Florida, 33606

  • Adobe Clinical Research , LLC

    Tucson, Arizona, 85712

  • Visions Clinical Research

    Tucson, Arizona, 85712

  • SC Clinical Research, Inc

    Tucson, Arizona, 85741

  • SC Clinical Research, Inc ,1060 E. Foothill Blvd, Suite 204

    Upland, California, 91786

  • Progressive Clinical Research

    Vista, California, 92084

  • Bay State Clinical Trials, Inc.

    Watertown, Massachusetts, 2472

  • Heartland Research Associates

    Wichita, Kansas, 67205

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: A,Randomized , Double-blind,Double -Dummy Placebo-controlled,Parallel -Group, Multicenter Study to Evaluate the Clinical Equivalence of Lubiprostone 24 mcg Capsules ( Dr. Reddy's Laboratories Ltd.) 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 manufactured by Dr Reddy's Laboratories Ltd compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation

Read the detailed description

Constipation is a common gastrointestinal problem estimated to effect 2-27 % of the population in United States . It is found more commonly in women and elderly . The prevelance of constipation and growing demand for treatment dictate the need for safe and effective treatment options . Lubiprostone is the first chloride channel activator approved by FDA for long term treatment of chronic idiopathic constipation in adult men and women . To provide a generic medicine to the U.S population Dr Reddy's Laboratories intends to conduct this study to evaluate that the Lubiprostone manufactured by it is equally effective and safe as marketed AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.)

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 to be given in the experimental arm with Placebo Of AMITIZA

  • LubiprostoneDrug

    24 mcg Capsules with placebo of Lubiprostone ( Manufactured by Dr Reddy's Laboratories Ltd)

  • PlaceboDrug

    24 mcg capsules of both experimental Lubiprostone and AMITIZA

Study groups in NCT01674530
Study groupRoleWhat they receive
LubiprostoneExperimentalManufactured by Dr Reddy's Laboratories Ltd( 24 mcg administered for 7 days )
Receives: Drug: Lubiprostone
AMITIZA®Active comparatorManufactured by Sucampo Pharmaceuticals(24 mcg administered for 7 days)
Receives: Drug: Lubiprostone
PlaceboPlacebo comparatorManufactured by Dr Reddy's Laboratories Ltd ( 24 mcg adminstered for 7 days )
Receives: Drug: Placebo

What is being measured

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

  1. 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 treatment period of the study

    Measured: Day 8

Timeline

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

  1. First posted29 Aug 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJan 2014
  4. Study completionMar 2014

Resources

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
909 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01674530
Sponsor's protocol ID
DRL-USG01-L/2012
Status last verified
Aug 2012
First submitted
21 Aug 2012
Last updated
3 Apr 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lubiprostone in people with Chronic Idiopathic Constipation, run by Dr. Reddy's Laboratories Limited at 93 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 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 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?

On the ClinicalTrials.gov record for NCT01674530.

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 3 Apr 2014.

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