Irritable ColonPhase 2NCT00101985
Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)
A Phase 2 study testing talnetant in people with Irritable Colon, run by GlaxoSmithKline at 135 sites in 11 countries.
Trial summary
This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Colon
- What is being tested?
- talnetant
- How many people
- 741 participants
- Where
- 135 sitesin 11 countries
- Study dates
- Oct 2004to Jul 2005
- Phase
- Phase 2
- 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
Who may be able to join
- Subjects will be required to conduct self-assessments of their IBS symptoms using a touch-tone telephone system for the duration of the study (15 weeks).
- Must be diagnosed with IBS consistent with the Rome II criteria.
- Must have normal results from a colonic procedure within 2 years of randomization.
- Must have conducted self-assessments on at least 12 days and have a documented average IBS pain or discomfort score of greater than or equal to 1.5 during the two-week screening phase.
Who cannot join
- Self-assessment of no stool for 7 days during the two-week screening phase.
- Clinically significant abnormal laboratory tests.
- Current evidence or history of various conditions, comorbidities, or surgeries such as Irritable Bowel Disease (IBD), gastrointestinal surgeries, and diverticulitis.
- Inability to use the touch-tone telephone system.
- Hypersensitivity to quinolone antibiotics or quinolone derivatives.
- Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose of medication for at least 6 months.
Show all 35Show fewer
- Women who are pregnant, breast feeding, or planning to become pregnant during the study.
- Permitted medications: The subject is allowed to take any of the following medications, provided they maintain a stable dose for at least 30 days prior to the Screening visit and throughout the remainder of the study:
- Antidepressants, except REMERON
- Antihypercholesterolemics
- Iron supplements
- Bulking agents
- Fiber supplement
- Thyroid replacement therapy (levothyroxine)
- Antipsychotics
- Cox-2 inhibitors (CELEBREX)
- Prohibited medications: Subjects must stop taking any medications they are taking to treat their IBS symptoms and must not have taken any of the prohibited medications at least 7 days prior to the Screening visit and must remain off these medications for the duration of the study.
- Anticholinergics (dicyclomine, hyoscyamine, propantheline)
- Cholinomimetic (bethanechol, pyridostigmine, tacrine, physostigmine)
- All narcotics (morphine, codeine, TYLENOL #3, propoxyphene, either alone or in combination)
- Tramadol hydrochloride (ULTRAM)
- Colchicine
- Orlistat (XENICAL)
- Misoprostol, alone or in combination (ARTHROTEC, CYTOTEC)
- 5-HT3 receptor antagonists (ondansetron, tropisetron, dolasetron, granisetron, mirtazapine, cilansetron, alosetron)
- Tegaserod (ZELNORM)
- Gabapentin
- Lupron
- Antacids containing magnesium or aluminium
- Antidiarrheal agents
- Bismuth compounds
- Prokinetic agents (cisapride, metoclopramide)
- Sulfasalazine
- Laxatives
- Cholestyramine
Trial locations and contacts
135 sites in 11 countries.
135 sites in 11 countries
United States70 sites
GSK Investigational Site
Akron, Ohio, 44310
GSK Investigational Site
Atlanta, Georgia, 30328
GSK Investigational Site
Austin, Texas, 78745
GSK Investigational Site
Blackwood, New Jersey, 08012
GSK Investigational Site
Boston, Massachusetts, 02118
GSK Investigational Site
Boulder, Colorado, 80304
GSK Investigational Site
Bristol, Connecticut, 06010
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Carmichael, California, 95608
GSK Investigational Site
Centennial, Colorado, 80112
GSK Investigational Site
Chandler, Arizona, 85224
GSK Investigational Site
Charlottesville, Virginia, 22911
GSK Investigational Site
Chaska, Minnesota, 55318
GSK Investigational Site
Chattanooga, Tennessee, 37404
GSK Investigational Site
Chesterfield, Michigan, 48047
GSK Investigational Site
Christiansburg, Virginia, 24073
GSK Investigational Site
Concord, California, 94520
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
East Syracuse, New York, 13057
GSK Investigational Site
El Paso, Texas, 79905
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Fishkill, New York, 12524
GSK Investigational Site
Florence, Kentucky, 41042
GSK Investigational Site
Garden Grove, California, 92840
GSK Investigational Site
Great Neck, New York, 11021
GSK Investigational Site
Greensboro, North Carolina, 27403
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Indianapolis, Indiana, 46237
GSK Investigational Site
Kettering, Ohio, 45429
GSK Investigational Site
Lacey, Washington, 98516
GSK Investigational Site
Lincoln, Nebraska, 68503
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Memphis, Tennessee, 38119
GSK Investigational Site
Memphis, Tennessee, 38120
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Newark, Delaware, 19713
GSK Investigational Site
Newtown, Pennsylvania, 18940
GSK Investigational Site
North Little Rock, Arkansas, 72117
GSK Investigational Site
Ogden, Utah, 84405
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Omaha, Nebraska, 68144
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Phoenix, Arizona, 85016
GSK Investigational Site
Pittsburgh, Pennsylvania, 15224
GSK Investigational Site
Portland, Oregon, 97225
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
Riverside, Illinois, 60546
GSK Investigational Site
Rochester, New York, 14607
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
Rockford, Illinois, 61107
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
Saint Joseph, Michigan, 49085
GSK Investigational Site
Salisbury, Massachusetts, 01952
GSK Investigational Site
San Antonio, Texas, 78209
GSK Investigational Site
Silver Spring, Maryland, 20901
GSK Investigational Site
Slidell, Louisiana, 70458
GSK Investigational Site
Spring Valley, California, 91978
GSK Investigational Site
Springfield, Massachusetts, 01107
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
St. Petersburg, Florida, 33707
GSK Investigational Site
St. Petersburg, Florida, 33709
GSK Investigational Site
Stamford, Connecticut, 06905
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
Torrance, California, 90506
GSK Investigational Site
Torrington, Connecticut, 06790
GSK Investigational Site
Wheat Ridge, Colorado, 80033
GSK Investigational Site
Wilmington, North Carolina, 28401
GSK Investigational Site
Wilmington, North Carolina, 28412
GSK Investigational Site
Winston-Salem, North Carolina, 27103
Canada16 sites
GSK Investigational Site
Edmonton, Alberta, T6G 2X8
GSK Investigational Site
Greater Sudbury, Ontario, P3E 6B4
GSK Investigational Site
Halifax, Nova Scotia, B3H 1V7
GSK Investigational Site
Mississauga, Ontario, L5A 1N1
GSK Investigational Site
Montreal, Quebec, H2X 3J4
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3
GSK Investigational Site
Québec, Quebec, G1S 4L8
GSK Investigational Site
Sainte Jerome, Quebec, J7Z 5T3
GSK Investigational Site
Sainte-Foy, Quebec, G1V 1V6
GSK Investigational Site
Saskatoon, Saskatchewan, S7K 1J5
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1
GSK Investigational Site
Sherbrooke, Quebec, J1H 5N4
GSK Investigational Site
Toronto, Ontario, M3J 1N2
GSK Investigational Site
Toronto, Ontario, M3N 2V7
GSK Investigational Site
Toronto, Ontario, M9W 4L6
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
Australia12 sites
GSK Investigational Site
Adelaide, South Australia, 5000
GSK Investigational Site
Bedford Park, South Australia, 5042
GSK Investigational Site
Box Hill, Victoria, 3128
GSK Investigational Site
Concord, New South Wales, 2139
GSK Investigational Site
Fitzroy, Victoria, 3065
GSK Investigational Site
Garran, Australian Capital Territory, 2606
GSK Investigational Site
Kippa-Ring, Queensland, 4021
GSK Investigational Site
Malvern, Victoria, 3144
GSK Investigational Site
Melbourne, Victoria, 3004
GSK Investigational Site
Newtown, New South Wales, 2042
GSK Investigational Site
Port Lincoln, South Australia, 5606
GSK Investigational Site
Spring Hill, Queensland, 4000
Germany9 sites
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, 23795
GSK Investigational Site
Berlin, State of Berlin, 10117
GSK Investigational Site
Berlin, State of Berlin, 10629
GSK Investigational Site
Berlin, State of Berlin, 13125
GSK Investigational Site
Chemnitz, Saxony, 09120
GSK Investigational Site
Dresden, Saxony, 01067
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20249
GSK Investigational Site
Leipzig, Saxony, 04107
GSK Investigational Site
Leipzig, Saxony, 04229
France8 sites
GSK Investigational Site
Caen, 14000
GSK Investigational Site
Clermont-Ferrand, 63058
GSK Investigational Site
Grenoble, 38043
GSK Investigational Site
Issoire, 63500
GSK Investigational Site
Marseille, 13002
GSK Investigational Site
Miramas, 13140
GSK Investigational Site
Nice, 06002
GSK Investigational Site
Vitry-sur-Seine, 94400
Spain5 sites
GSK Investigational Site
Badalona, 08916
GSK Investigational Site
Barcelona, 08022
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Oviedo, 33006
United Kingdom5 sites
GSK Investigational Site
Blackpool, Lancashire, FY2 9RS
GSK Investigational Site
Blackpool, Lancashire, FY4 3AD
GSK Investigational Site
Leeds, LS12 1JE
GSK Investigational Site
Northwood, Middlesex, HA6 2RN
GSK Investigational Site
Portergate, Sheffield, S11
South Africa4 sites
GSK Investigational Site
Claremont, 7708
GSK Investigational Site
N1 City, 7460
GSK Investigational Site
Parktown, 2193
GSK Investigational Site
Somerset West, 7130
Sweden4 sites
GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Nacka, SE-131 83
GSK Investigational Site
Stockholm, SE-141 86
GSK Investigational Site
Stockholm, SE-171 76
Location not given1 site
GSK Investigational Site
About this study
Official title: An Eight-week, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate Efficacy and Safety of Talnetant in Subjects With Irritable Bowel Syndrome
This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS).
- Conditions
- Irritable Colon
- Being tested
- talnetant
- Keywords
- Quality of Life, Irritable bowel syndrome, IBS, SB223412, Qol
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talnetantDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether talnetant provided adequate relief from IBS pain and discomfort for at least one of three talnetant dose groups compared with placebo and to determine the safety and tolerability of talnetant in subjects with IBS.
Secondary outcomes (1)
- Explore response among subgroups IBS. - Evaluate positive treatment effects within bowel subgroups. - Compare treatment groups for global improvement of IBS symptoms. - Improvement of IBS pain or discomfort, Quality of Life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2005 (estimated)
- Study startOct 2004
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable ColonStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 741 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101985
- Sponsor's protocol ID
- 223412/068
- Status last verified
- Apr 2015
- First submitted
- 18 Jan 2005
- Last updated
- 13 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-week, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate Efficacy and Safety of Talnetant in Subjects With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00101985
- Acronym / sponsor ID
- 223412/068
- Conditions
- Irritable Colon
- Keywords
- Quality of Life, Irritable bowel syndrome, IBS, SB223412, Qol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 741 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 19 Jan 2005 (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 investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects will be required to conduct self-assessments of their IBS symptoms using a touch-tone telephone system for the duration of the study (15 weeks).
- Must be diagnosed with IBS consistent with the Rome II criteria.
- Must have normal results from a colonic procedure within 2 years of randomization.
- Must have conducted self-assessments on at least 12 days and have a documented average IBS pain or discomfort score of greater than or equal to 1.5 during the two-week screening phase.
Key exclusion criteria (35 listed)
- Self-assessment of no stool for 7 days during the two-week screening phase.
- Clinically significant abnormal laboratory tests.
- Current evidence or history of various conditions, comorbidities, or surgeries such as Irritable Bowel Disease (IBD), gastrointestinal surgeries, and diverticulitis.
- Inability to use the touch-tone telephone system.
- Hypersensitivity to quinolone antibiotics or quinolone derivatives.
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 |
|---|---|---|
| talnetant | Drug | – |
Primary outcome
Determine whether talnetant provided adequate relief from IBS pain and discomfort for at least one of three talnetant dose groups compared with placebo and to determine the safety and tolerability of talnetant in subjects with IBS.
1 secondary outcome
- Explore response among subgroups IBS. - Evaluate positive treatment effects within bowel subgroups. - Compare treatment groups for global improvement of IBS symptoms. - Improvement of IBS pain or discomfort, Quality of Life.
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 13 Apr 2015.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
135 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing talnetant in people with Irritable Colon, run by GlaxoSmithKline at 135 sites in 11 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 4 inclusion and 35 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 135 sites in United States, Canada, Australia, Germany, France and 5 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. 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?
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?
Determine whether talnetant provided adequate relief from IBS pain and discomfort for at least one of three talnetant dose groups compared with placebo and to determine the safety and tolerability of talnetant in subjects with IBS.. 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 13 Apr 2015.