Pulmonary TuberculosisPhase 2NCT00401271
Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis
A Phase 2 study testing OPC-67683 and Rifafour e-275 in people with Pulmonary Tuberculosis, run by Otsuka Frankfurt Research Institute GmbH at 3 sites in South Africa.
Trial summary
The purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg, 200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days, in patients with uncomplicated, smear-positive pulmonary TB. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- OPC-67683 and Rifafour e-275
- How many people
- 54 participants
- Where
- 3 sitesSouth Africa
- Study dates
- Nov 2006to Mar 2007
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provide written, informed consent prior to all trial-related procedures.
- Male and female patients aged between 18 and 64 years, inclusive.
- Newly diagnosed, previously untreated, uncomplicated, smear positive, pulmonary TB.
- A chest X-ray finding compatible with TB.
- Sputum positive on direct microscopy for acid-fast bacilli (AFB) (at least 1+).
- Able to produce an adequate volume of sputum (10mL or more estimated overnight production).
- Female patients of childbearing potential must demonstrate a negative pregnancy test result. Furthermore they must agree to use a highly effective method of contraception.
- Male patients must agree to use an adequate method of contraception.
Who cannot join
- Poor general condition where no delay in treatment can be tolerated or where immediate hospital admission is warranted.
- Rifampicin-resistant bacteria detected in the sputum susceptibility testing at Screening.
- Treatment received with any drug active against M. tuberculosis within the 3 months prior to Screening.
- History of allergy to any nitro-imidazole derivates, rifamycin derivatives, isoniazid derivatives, pyrazinamide or ethambutol.
- Clinical evidence of severe extrathoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis).
- Evidence of pulmonary silicosis, lung fibrosis, or other lung condition considered as severe by the investigator (other than TB).
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- Presence of chronic obstructive pulmonary disease or asthma.
- Any clinically relevant concomitant conditions or renal impairment characterized by serum creatinine levels >= 1.5xULN or hepatic impairment or alcohol abuse characterized by ALT and/or aspartate transferase (AST) levels 3xULN and/or gamma-glutamyl transpeptidase (GGT) levels 3xULN of the laboratory reference range.
- Known or suspected alcohol or drug abuse, that is, abuse sufficient enough to compromise the safety or cooperation of the patient, in the opinion of the investigator, and as evident by a positive urine drug screen.
- Neuropathy, psychosis or epilepsy.
- Clinically relevant changes in the ECG such as atrioventricular (AV) block, prolongation of the QRS complex >120 milliseconds (in both male and female patients), or QTcB interval >430 milliseconds in male patients and >450 milliseconds in female patients. Family history of long QT syndromes and/or Torsade de Pointes.
- History of or current clinically relevant cardiovascular disorder such as hypokalaemia, heart failure, coronary heart disease, hypertension, arrhythmia or symptom strongly suggestive of such a problem (for example, syncope or palpitations), tachyarrhythmia or status after myocardial infarction.
- Known bleeding disorders or family history of bleeding disorders.
- Diabetes treated with insulin.
- Evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied).
- Any diseases or conditions in which the use of rifampicin, isoniazid, pyrazinamide or ethambutol is contra-indicated.
- Any disease or conditions in which any of the medicinal products listed in the protocol, is used. Treatment received with quinolones and prednisolone within 3 months prior to Screening.
- Administration of an IMP within 1 month prior to Screening.
- Pregnancy, breast-feeding, or planning to conceive or father a child within the timeframe described in the informed consent form.
- Recent use of methadone, benzodiazepines, cocaine, amphetamine/metamphetamine, tetrahydrocannabinol, barbiturates, tricyclic antidepressants, and opiates as determined by a urine drug screen.
- Helper/inducer T lymphocyte (CD4 cell) count of <=350x106/L.
- Use of antiretroviral therapy.
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
Tiervlei Trial Center, Karl Bremer Hospital
Bellville, W Cape, 7531
Medical Research Council
Durban, 4000
University of Cape Town Lung Institute
Mowbray, W Cape, 7700
About this study
Official title: A Phase II Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Four Oral Doses of OPC-67683 in Patients With Uncomplicated, Smear-Positive, Pulmonary Tuberculosis
The purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg, 200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days, in patients with uncomplicated, smear-positive pulmonary TB.
The four OPC-67683 treatment groups will comprise 12 patients each and the one standard therapy (Rifafour e-275) group six patients.
Trial 242-06-101 is an exploratory and not a confirmatory trial and as such no hypothesis will be tested statistically.
The control group, six patients treated with Rifafour, will serve as an control to confirm the microbiological assessments during the trial.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- OPC-67683, Rifafour e-275
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-67683Drug
Rifafour e-275Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
TB bacterial load in sputum measured as colony forming units
Secondary outcomes (3)
Early Bactericidal Activity (EBA)
Slope 0-14
Tme to culture positivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startNov 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies 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
- None (open label)
- Enrolment
- 54 participants
Sponsor and investigators
- Lead sponsor
- Otsuka Frankfurt Research Institute GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andreas H Diacon, Dr., Principal investigator, Tiervlei Trial CenterRoxana Rustomjee, Dr., Principal investigator, Medical Research CouncilRodney Dawson, Dr., Principal investigator, University of Cape Town Lung Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401271
- Sponsor's protocol ID
- 242-06-101
- Status last verified
- Mar 2007
- First submitted
- 17 Nov 2006
- Last updated
- 7 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Four Oral Doses of OPC-67683 in Patients With Uncomplicated, Smear-Positive, Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT00401271
- Acronym / sponsor ID
- 242-06-101
- Conditions
- Pulmonary Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants
- Lead sponsor
- Otsuka Frankfurt Research Institute GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Mar 2007
- First posted
- 20 Nov 2006 (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 purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg, 200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days, in patients with uncomplicated, smear-positive pulmonary TB.
The four OPC-67683 treatment groups will comprise 12 patients each and the one standard therapy (Rifafour e-275) group six patients.
Trial 242-06-101 is an exploratory and not a confirmatory trial and as such no hypothesis will be tested statistically.
The control group, six patients treated with Rifafour, will serve as an control to confirm the microbiological assessments during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Provide written, informed consent prior to all trial-related procedures.
- Male and female patients aged between 18 and 64 years, inclusive.
- Newly diagnosed, previously untreated, uncomplicated, smear positive, pulmonary TB.
- A chest X-ray finding compatible with TB.
- Sputum positive on direct microscopy for acid-fast bacilli (AFB) (at least 1+).
Key exclusion criteria (22 listed)
- Poor general condition where no delay in treatment can be tolerated or where immediate hospital admission is warranted.
- Rifampicin-resistant bacteria detected in the sputum susceptibility testing at Screening.
- Treatment received with any drug active against M. tuberculosis within the 3 months prior to Screening.
- History of allergy to any nitro-imidazole derivates, rifamycin derivatives, isoniazid derivatives, pyrazinamide or ethambutol.
- Clinical evidence of severe extrathoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis).
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 |
|---|---|---|
| OPC-67683 | Drug | – |
| Rifafour e-275 | Drug | – |
Primary outcome
TB bacterial load in sputum measured as colony forming units
3 secondary outcomes
Early Bactericidal Activity (EBA)
Slope 0-14
Tme to culture positivity
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 7 Mar 2007.
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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.
Andreas H Diacon, Dr. principal investigator
Tiervlei Trial Center
Roxana Rustomjee, Dr. principal investigator
Medical Research Council
Rodney Dawson, Dr. principal investigator
University of Cape Town Lung Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPC-67683 and Rifafour e-275 in people with Pulmonary Tuberculosis, run by Otsuka Frankfurt Research Institute GmbH at 3 sites in South Africa.
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 7 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. 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?
TB bacterial load in sputum measured as colony forming units. 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 7 Mar 2007.