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Safety and Efficacy Trial of Delamanid for 6 Months in Patients With Multidrug Resistant Tuberculosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01424670
First received: August 25, 2011
Last updated: January 30, 2017
Last verified: January 2017
August 25, 2011
January 30, 2017
September 2011
May 2014   (Final data collection date for primary outcome measure)
Time to Sputum Culture Conversion [ Time Frame: 6 months ]
Distribution of the time to SCC during the 6-months of IMP treatment.
  • Sputum Culture Conversion [ Time Frame: 2 months ]
    Proportion of patients achieving SCC at 2 months.
  • Time to Sputum Culture Conversion [ Time Frame: 6 months ]
    Distribution of the time to SCC during the 6-months of IMP treatment.
Complete list of historical versions of study NCT01424670 on ClinicalTrials.gov Archive Site
  • Time to Sputum Culture Converstion [ Time Frame: 6 Months ]
    Distribution of the time to SCC by 6 months
  • Treatment Outcomes [ Time Frame: 30 months ]
    Treatment outcomes assessed by principal investigators at the end of treatment with OBR
  • Sputum Culture Conversion [ Time Frame: 2 months ]
    Proportion of patients with SCC at 2 months
  • Sputum Culture Conversion [ Time Frame: 6 months ]
    Proportion of patients with SCC at 6 months
  • Sustained Sputum Culture Conversion [ Time Frame: 30 months ]
    SCC between Month 18 and Month 30
  • Outcome [ Time Frame: 30 Months ]
    Final outcome at Month 30 as treatment success or failure
  • Mean Change in TTD [ Time Frame: 30 Months ]
    Mean change from baseline in time to detection (TTD)
  • Mean AUC of Change in TTD [ Time Frame: 30 Months ]
    Mean AUC of change from baseline in time to detection (TTD)
  • Development of Resistance to Delamanid [ Time Frame: 30 Months ]
    Proportion of patients who develop resistance to delamanid
  • Sputum Culture Conversion [ Time Frame: 2 months ]
    Proportion of patients with SCC using solid culture media
  • Sputum Culture Conversion [ Time Frame: 6 months ]
    Proportion of patients with SCC using the MGIT system
  • Durability of Sputum Culture Conversion [ Time Frame: 18 months ]
    Durability of SCC with the MGIT system during the Continuation Treatment and Post-treatment Follow-up periods
  • Time to Sputum Culture Conversion [ Time Frame: 6 months ]
    Distribution of the time to SCC using solid culture media during 6-months of IMP treatment.
  • Sputum Culture Conversion [ Time Frame: 6 months ]
    Proportion of patients with SCC using solid culture media
  • Durability of Sputum Culture Conversion [ Time Frame: 30 Months ]
    Durability of SCC with the MGIT system during the Continuation Treatment and Post-treatment Follow-up periods
  • Changes in S/S of TB [ Time Frame: 30 Months ]
    Change in clinical signs and symptoms of TB
  • Mortality [ Time Frame: 30 Months ]
    Proportion of mortality associated with TB
  • Mortality [ Time Frame: 30 Months ]
    Proportion of all-cause mortality in each group
Not Provided
 
Safety and Efficacy Trial of Delamanid for 6 Months in Patients With Multidrug Resistant Tuberculosis
A Phase 3, Multicenter,Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid Administered Orally as 200 mg Total Daily Dose for Six Months in Patients With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis
The purpose of this trial is to determine whether delamanid is effective in the treatment of Multidrug-resistant Tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.
The purpose of this trial is to evaluate the efficacy of delamanid administered orally as 100 mg twice daily (BID) for 2 months followed by 200 mg once daily (QD) for 4 months in combination with an optimized background regimen (OBR) versus placebo with OBR during the 6-month intensive phase of MDR TB treatment. This trial is a multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted globally in 2 parallel groups at approximately 18 sites in 7 countries qualified to treat MDR TB. In addition, a subtrial comprised of human immunodeficiency virus (HIV) positive patients who will be on antiretrovirals (ARVs) during the trial and will be randomized to OBR plus placebo or OBR plus delamanid will be conducted sites in South Africa that have been prequalified as having an integrated approach to TB and HIV treatment and management and a sufficient population of MDR TB patients co-infected with HIV for enrollment.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Multidrug Resistant Tuberculosis
  • Drug: Delamanid
    100mg BID for 2 months and 200mg QD for 4 months
  • Drug: Placebo
    Matching Placebo
  • Drug: Optimized Background Regimen (OBR)
    • Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country. ARVs will be administered as standard-of-care.
  • Drug: Antiretrovirals (ARVs)
    • HIV treatment (i.e. ARVs) will be based on WHO guidelines and recommendations, and in compliance with local/national guidelines for HIV in South Africa (each site). ARVs will be administered as standard-of-care.
  • Placebo Comparator: Placebo tablet
    Matching Placebo tablet
    Interventions:
    • Drug: Placebo
    • Drug: Optimized Background Regimen (OBR)
    • Drug: Antiretrovirals (ARVs)
  • Experimental: Delamanid
    100mg BID for 2 months and 200mg QD for 4 months
    Interventions:
    • Drug: Delamanid
    • Drug: Optimized Background Regimen (OBR)
    • Drug: Antiretrovirals (ARVs)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
511
June 2016
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provide written, informed consent
  • Current Diagnosis of MDR TB
  • Chest radiograph consistent with TB
  • Able to produce sputum
  • Negative urine pregnancy test and agree to use a highly effective method of birth control and/or adequate method of contraception

Exclusion Criteria:

  • Allergy to any nitro-imidazoles or nitro-imidazole derivates
  • Diseases or conditions in which the use of nitro-imidazoles or nitro-imidazole derivates is contra-indicated
  • Use of disallowed medications
  • Renal impairment
  • Abnormal ECG
  • Cardiovascular disorders
  • BMI < 16 kg/m2
  • Karnofsky score < 50%
  • Significant metabolic, gastrointestinal, neurological, psychiatric, or endocrine diseases, active malignancy
  • Alcohol abuse
  • Pregnant, breast-feeding, or planning to conceive or father a child
  • Recent use of methadone, benzodiazepines, cocaine, amphetamine/metamphetamine, tetrahydrocannabinol, barbiturates, and opiates
  • Previous exposure to delamanid
  • Administered an IMP within 1 month prior to Visit 1
  • Evidence of XDR TB based on the definition from WHO
  • HIV co-infection for patients screened at sites not participating in the HIV subtrial
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Estonia,   Latvia,   Lithuania,   Moldova, Republic of,   Peru,   Philippines,   South Africa
India
 
NCT01424670
242-09-213
Yes
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
Study Director: Rajesh Gupta, MD Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP