AzTrials
AzTrials

Inflammatory Bowel DiseasePhase 3NCT00321412

Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas

A Phase 3 study testing AST-120 in people with Inflammatory Bowel Disease and Intestinal Fistula, run by Ocera Therapeutics at 88 sites in 12 countries.

Completed

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

Official record
Search all trials

Trial summary

The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
AST-120
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
191 participants
Where
88 sitesin 12 countries
Study dates
Mar 2006to Sep 2008
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body Weight > or = 40kg
  • Documented diagnosis of Crohn's disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis
  • Presence of at least one draining fistula. Patients with enterocutaneous fistulas can be included if they have > or = 1 draining perianal fistula. Women with rectovaginal fistulas can be included if they have > or = 1 draining perianal fistula.
  • Crohn's Disease Activity Index (CDAI) score < 400
  • Platelet count (thrombocytes) > or = 100,000/uL
  • Able and willing to comply with all protocol procedures for the duration of the study
  • Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information
  • Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (hormonal contraceptives, intrauterine devices, spermicide and barrier). Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.

Who cannot join

  • Non-response to infliximab or other biological immunosuppressants/ immunomodulators for fistulas associated with Crohn's disease (response is defined as a > or = 50% reduction from baseline in the number of fistulas over at least four weeks); patients who respond once to infliximab and eventually fail can be included
  • Infliximab (and/or other biological immunosuppressant/immunomodulatory) therapy within 3 months prior to enrollment in the study
  • Presence of symptomatic strictures or suggestion of significant clinical obstruction
  • Patients with setons are excluded, unless the setons are removed within 48 hours prior to study entry
  • Presence of entero-entero, recto-vesicular, entero-vesicular fistulas
  • Platelet count (thrombocytes) < 100,000/uL
Show all 22Show fewer
  • CDAI score of > or = 400
  • Patient is unable to stay on a stable dose of concomitant Crohn's disease medication(s) for at least 10 weeks in the opinion of the investigator
  • Currently symptomatic untreated diarrhea due to conditions other than mild to moderately active Crohn's disease (e.g., bacterial or parasitic gastroenteritis, bile salt diarrhea, etc.)
  • Severe diarrhea defined by > 10 liquid bowel movements per day
  • Other local manifestations of mild to moderately active Crohn's disease such as abscesses, or other disease manifestations for which surgery might be indicated or which might preclude utilization of a CDAI to assess response to therapy (e.g., short bowel syndrome)
  • Presence of an ileostomy
  • Receiving Total Parenteral Nutrition (TPN) as the sole source of nutrition within 3 weeks of Screen
  • Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling.
  • Hemoglobin < 8.5 g/dL (females) or hemoglobin < 10 g/dL (males) at Screen
  • Women who are pregnant, breast feeding, or planning to become pregnant during the study
  • Other major physical or major psychiatric illness within the last 6 months that in the opinion of the investigator would affect the patient's ability to complete the trial
  • Uncontrolled systemic disease
  • Patients undergoing chemotherapy for the treatment of cancer
  • Known hypersensitivity or contraindication to any component of the test product (study drugs) or diagnostics used
  • Participation in another study within eight (8) weeks prior to the study
  • Unable to attend all visits required by the protocol

Trial locations and contacts

88 sites in 12 countries.

88 sites in 12 countries

United States25 sites

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Digestive Disease Center/MUSC

    Charleston, South Carolina, 29425

  • Carolina Digestive Health Associates

    Charlotte, North Carolina, 28211

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Metropolitan Gastroenterology Group/Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637-1426

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic - Department of Gastroenterology

    Cleveland, Ohio, 44195

  • Drs. Scherf, Chessler, Zingler & Spinnell, MD, PA

    Fort Lee, New Jersey, 07024

  • Memphis Gastroenterology Group, PC

    Germantown, Tennessee, 38138

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York, 11021

  • The Penn State University, Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Indiana University, Outpatient Clinical Research Facility

    Indianapolis, Indiana, 46202

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • University of Louisville, Department of Surgery

    Louisville, Kentucky, 40202

  • Dean Foundation Research Center

    Madison, Wisconsin, 53715

  • Mount Sinai School of Medicine, IBD Research Center

    New York, New York, 10028

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Digestive Care Medical Center

    San Carlos, California, 94070

  • University of Washington

    Seattle, Washington, 98195

  • Shafran Gasteroenterology Center

    Winter Park, Florida, 32789

Other trials in United States

Germany11 sites

  • Universitatsklinikum Aachen

    Aachen, 52074

  • Charite-Campus Virchow-Klinikum

    Berlin, D-13353

  • Klinikum der Johann-Wolfgang-Goethe Universitat Frankfurt am Main

    Frankfurt, 60590

  • Medizinische Hochschule Hannover

    Hanover, D-30623

  • Universitatsklinik Heidelberg Abteilung Gastroenterologie und Hepatologie

    Heidelberg, D-69120

  • Universitatsklinikum Schleswig-Holstein

    Kiel, D-24105

  • Klinikum rechts der Isar der TUM II

    München, 81675

  • Universitatsklinikum Regensburg

    Regensburg, 93047

  • Universitat Rostock - Midizinische Fakultat

    Rostock, D-18057

  • Medizinische Universitatsklinik Tubingen

    Tübingen, D-72026

  • Universitatsklinikum Ulm

    Ulm, D-89081

Other trials in Germany

France9 sites

  • CHU Hopital Nord, Service de Gastro-enterologie et nutrition

    Amiens, 80054

  • Hopital de la Cote de Nacre - CHU

    Caen, 14033

  • CHU de Grenoble - Hopital Nord

    Grenoble, 38043

  • Hopital Claude Huriez, Service des maladies de l'appareil disgestif

    Lille, 59037

  • Hopital Nord, Service de Gastro-Enterologie

    Marseille, 13915

  • Hopital Saint-Eloi, Service de Gastro-enterologie et transplantation

    Montpelier, 34295

  • CHU Hotel Dieu, Institut des Maladies de l'Appareil Digestif

    Nantes, 44093

  • CHU de Nice - Hopital de l'Archet 2

    Nice, 06202

  • Hopital Leopold Bellan

    Paris, 75674

Other trials in France

Israel7 sites

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 31096

  • Strauss Medical Center

    Jerusalem, 95146

  • Meir Hospital

    Kfar Saba, 44281

  • Rabin Medical Center, Bellinson Hospital

    Petah Tikva, 48100

  • Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 76100

Other trials in Israel

Poland7 sites

  • Samodzielny Publiczny Centralny Szpital Kliniczny Slaskiej AM

    Katowice, 40-752

  • Zakaznych Szpitala Uniwersyteckiego w Krakowie

    Krakow, 31-531

  • Korektalnej Uniwersytetu Medycznego w Lodzi

    Lodz, 90-647

  • University Hospital Olomouc, 2nd Internal Department

    Olomouc, 775 20

  • Samodzielny Publiczny Szpital Kliniczny Nr 2 im. Heliodora

    Poznan, 06-355

  • Samodzielny Publiczny Centralny Szpital

    Warsaw, 02-097

  • Katedra Klinika Gastroenterologi, Akedemil Medycanej we Wroclawiu

    Wroclaw, 50-326

Other trials in Poland

United Kingdom6 sites

  • Bristol Royal Infirmary, Dept. of Gastroenterology

    Bristol, BS2 8HW

  • Countess of Chester Hospital

    Chester, CH2 1UL

  • Crosshouse Hospital

    Kilmarnock, KA2 0BE

  • Leicester General Hospital - GI Research Unit

    Leicester, LE5 4PW

  • University College London Hospital, Dept. of Gastroenterology

    London, NW1 2BU

  • John Radcliffe Hospital, Dept. of Gastroenterology

    Oxford, OX3 9DU

Other trials in United Kingdom

Canada5 sites

  • GILDR Group, University of Edmonton

    Edmonton, Alberta, T6G 2X8

  • McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5

  • London Health Sciences Center

    London, Ontario, N6A 4G5

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Liver & Intestinal Research Centre

    Vancouver, British Columbia, V5Z 1H2

Other trials in Canada

Czechia5 sites

  • University Hospital Brno, Internal and Gastroenterology Department

    Brno, 625 00

  • Regional Hospital Liberec, Department of Gastroenterology

    Liberec, 460 63

  • University Hospital Prague 2, 4th Department of Internal Medicine

    Prague, 120 00

  • Thomayer's University Hospital Prague, 2nd Internal Department

    Prague, 140 00

  • Institute for Clinical and Experimental Medicine

    Prague, 140 21

Other trials in Czechia

Hungary5 sites

  • Peterfy Sandor utcai Korhaz-Rendelointezet

    Budapest, H-1076

  • Semmelweis Egyetem

    Budapest, H-1083

  • Semmelweis Egyetem

    Budapest, H-1088

  • Miskolc Megyei Jogu Onkormanyzat Semmelweis Oktato Korhaz-Rendelointezet

    Miskolc, H-3501

  • Szegedi Tudomanyegyetem, I.sz. Belgyogyaszati Klinika

    Szeged, H-6701

Other trials in Hungary

Belgium4 sites

  • Imelda General Hospital

    Bonheiden, B-2820

  • St. Jansziekenhuis/Ziekenhuis Oost-Limburg

    Genk, 3600

  • University Hospital Gasthuisberg, University of Leuven

    Leuven, 3000

  • H.-Hartziekenhuis Roeselare-Menen vzw

    Roeselare, 8800

Other trials in Belgium

Austria3 sites

  • Univ Klinik fur Innere Medizin Innsbruck

    Innsbruck, 6020

  • Universitatsklinik fur Innere Medizin I der PMU

    Salzburg, 5020

  • AKH Wien - Univ Klinik Innere Med IV

    Vienna, 1090

Other trials in Austria

Netherlands1 site

  • Erasmus MC, Department of Gastroenterology and Hepatology

    Rotterdam, 3015 CE

Other trials in Netherlands

About this study

Official title: A Double-blind, Randomized, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Mild to Moderately Active Crohn's Patients With Fistulas

The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).

Read the detailed description

The experimental drug AST-120 is composed of black, odorless spherical carbon particles in 2g sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose spheres, Celphere CP-305, stained to match the appearance of AST-120, in 2g sachets (aluminum foil pouches). Both AST-120 and placebo are oral (taken by mouth)preparations. Both are tasteless. To take the product, patients will tear open the sachets, drop the contents directly on their tongue and wash it down with 8 ounces of water.

Patients will be randomly assigned (like the toss of a coin), to receive either AST-120 or placebo. Patients will have a 50/50 chance of receiving placebo. Patients who participate in this study will be required to take a single dose of study drug (AST-120 or placebo) 3 times a day, 30 minutes after a meal, for 8 weeks, and be evaluated at Week 4 and Week 8. This is a 'blinded' treatment, which means that neither the patient nor the study doctor will know if the patient has received study drug or placebo.

If, at the end of the first full course of randomized treatment, (8 weeks), patients are not showing an improvement in their condition, they may have the option to receive the alternate blinded treatment for one treatment course (8 weeks). The study doctor will discuss this option with each patient individually. During this second course of treatment, patients will be evaluated at Week 12 and Week 16. If the patient does not respond to the alternate blinded treatment, or their condition worsens after 4 weeks (assessed at Week 12), they may be removed from the study at the discretion of the investigator.

If patients respond to either the initial treatment or the alternate blinded treatment, they will have monthly doctor/clinic visits for up to 6 months (Week 24), or until their condition worsens or they relapse. Patients will not receive any study drug during this follow-up period.

Relapse is defined for this study as:

  • an increase by 1 or more in the number of draining fistulas for 2 sequential visits versus the number present at the time of response (response is defined as at least a 50% reduction in the number of draining fistulas at either Week 8, or for those patients receiving alternate blinded treatment, Week 16).

There are a maximum of 8 patient evaluation visits in this study (Screen, Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24). Evaluations at most of these visits include a review of concomitant medications, medical history/adverse events, physical exam, fistula exam, blood draws for safety labs, urine pregnancy tests for females, and measurement of body weight. Patients will also be asked to keep a daily diary to record frequency of bowel movements, general well-being, and use of antidiarrheal medication.

Treatment failure in this study is defined by one or more of the following occurring prior to Week 8:

  • The need for additional therapies or dose increase for treatment of Crohn's disease, including an increase of corticosteroid dose to higher than baseline
  • Clinical/symptomatic development of an abscess
  • Clinical/symptomatic evidence of stricture
  • The need for surgical intervention for Crohn's disease
  • The patient withdraws from the study

Patients will be discontinued from the study at any time if one or more of the following complications occur:

  • Development of an abscess or symptomatic stricture
  • The need for surgical intervention for Crohn's disease
  • Occurrence of any other event that in the opinion of the investigator warrants discontinuation of the patient from the study

In addition, patients whose CDAI score has risen by > or = 70 points above baseline or risen above 400 will be discontinued from the study.

Administration of any additional therapies or dose increases of concomitant medications (including corticosteroids) to control Crohn's disease to higher than baseline while receiving study drug (initial randomized treatment or alternate blinded treatment) will require discontinuation of the patient from the study.

Discontinued patients will be evaluated in a termination visit to document the lack of treatment efficacy and no further study treatment will be given.

Being tested
AST-120
Keywords
Crohn's disease, IBD, Inflammatory Bowel Disease, Fistula
Medical subject headings
Inflammatory Bowel Diseases, Intestinal Fistula, Crohn Disease, Fistula

What participants receive

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

  • AST-120Drug

    oral, sachet, 2 grams three times daily for 8 weeks

Study groups in NCT00321412
Study groupRoleWhat they receive
2Placebo comparatorCelphere® CP-305, stained to match appearance of AST-120, in 2g sachets
Receives: Drug: AST-120
1ExperimentalAST-120, 2 gram sachets
Receives: Drug: AST-120

What is being measured

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

  1. Efficacy: The proportion of patients considered to be "treatment successes" defined by a reduction of at least 50% in the number of draining fistulas at both week 4 and week 8 of an 8 week treatment period

    Measured: 8 weeks

  2. Safety: Adverse events deemed possibly, probably or definitely related to study drug during 8 weeks of treatment

    Measured: 8 weeks

Secondary outcomes (6)

  1. Efficacy: 100% non-draining fistulas at both week 4 and week 8

    Measured: 8 weeks

  2. Efficacy: Fistula response at Week 8

    Measured: 8 weeks

  3. Efficacy: Change in CDAI scores from baseline over 8 weeks of treatment

    Measured: 8 weeks

  4. Safety: Clinical laboratory tests (electrolytes)

    Measured: 8 weeks

  5. Safety: Development of abscesses

    Measured: 8 weeks

  6. Safety: Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature)

    Measured: 8 weeks

Timeline

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

  1. First posted3 May 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionMar 2008
  4. Study completionSep 2008

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00321412
Sponsor's protocol ID
AST001
Status last verified
May 2014
First submitted
1 May 2006
Last updated
30 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • Hay JW, Hay AR. Inflammatory bowel disease: costs-of-illness. J Clin Gastroenterol. 1992 Jun;14(4):309-17. doi: 10.1097/00004836-199206000-00009.

    PubMed 1607607

  • Hugot JP, Chamaillard M, Zouali H, Lesage S, Cezard JP, Belaiche J, Almer S, Tysk C, O'Morain CA, Gassull M, Binder V, Finkel Y, Cortot A, Modigliani R, Laurent-Puig P, Gower-Rousseau C, Macry J, Colombel JF, Sahbatou M, Thomas G. Association of NOD2 leucine-rich repeat variants with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):599-603. doi: 10.1038/35079107.

    PubMed 11385576

  • Ogura Y, Bonen DK, Inohara N, Nicolae DL, Chen FF, Ramos R, Britton H, Moran T, Karaliuskas R, Duerr RH, Achkar JP, Brant SR, Bayless TM, Kirschner BS, Hanauer SB, Nunez G, Cho JH. A frameshift mutation in NOD2 associated with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):603-6. doi: 10.1038/35079114.

    PubMed 11385577

  • Best WR, Becktel JM, Singleton JW. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology. 1979 Oct;77(4 Pt 2):843-6.

    PubMed 467941

  • Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. doi: 10.1053/gast.2002.32362.

    PubMed 11910338

  • Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.

    PubMed 7429313

  • Farmer RG, Hawk WA, Turnbull RB Jr. Clinical patterns in Crohn's disease: a statistical study of 615 cases. Gastroenterology. 1975 Apr;68(4 Pt 1):627-35. No abstract available.

    PubMed 1123132

  • Gray BK, Lockhartmummery HE, Morson BC. Crohn's disease of the anal region. Gut. 1965 Dec;6(6):515-24. doi: 10.1136/gut.6.6.515. No abstract available.

    PubMed 5857889

  • Schwartz DA, Pemberton JH, Sandborn WJ. Diagnosis and treatment of perianal fistulas in Crohn disease. Ann Intern Med. 2001 Nov 20;135(10):906-18. doi: 10.7326/0003-4819-135-10-200111200-00011.

    PubMed 11712881

  • Schwartz DA, Herdman CR. Review article: The medical treatment of Crohn's perianal fistulas. Aliment Pharmacol Ther. 2004 May 1;19(9):953-67. doi: 10.1111/j.1365-2036.2004.01917.x.

    PubMed 15113362

  • Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(18):1398-405. doi: 10.1056/NEJM199905063401804.

    PubMed 10228190

  • Present DH, Korelitz BI, Wisch N, Glass JL, Sachar DB, Pasternack BS. Treatment of Crohn's disease with 6-mercaptopurine. A long-term, randomized, double-blind study. N Engl J Med. 1980 May 1;302(18):981-7. doi: 10.1056/NEJM198005013021801.

    PubMed 6102739

  • Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.

    PubMed 12047962

  • Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. doi: 10.1056/NEJMoa030815.

    PubMed 14985485

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AST-120 in people with Inflammatory Bowel Disease and Intestinal Fistula, run by Ocera Therapeutics at 88 sites in 12 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 8 inclusion and 22 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 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Germany, France, Israel, Poland and 7 more countries. 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?

Efficacy: The proportion of patients considered to be "treatment successes" defined by a reduction of at least 50% in the number of draining fistulas at both week 4 and week 8 of an 8 week treatment period (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT00321412, which also lists 14 linked publications.

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 30 May 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in