Safety and Efficacy Trial of Delamanid for 6 Months in Patients With Multidrug Resistant Tuberculosis
This study is currently recruiting participants.
Verified December 2012 by Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01424670
First received: August 25, 2011
Last updated: December 4, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multidrug Resistant Tuberculosis |
Drug: Delamanid Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Primary Outcome Measures:
- Sputum Culture Conversion [ Time Frame: 2 months ] [ Designated as safety issue: No ]Proportion of patients achieving SCC at 2 months.
- Time to Sputum Culture Conversion [ Time Frame: 6 months ] [ Designated as safety issue: No ]Distribution of the time to SCC during the 6-months of IMP treatment.
Secondary Outcome Measures:
- Sputum Culture Conversion [ Time Frame: 2 months ] [ Designated as safety issue: No ]Proportion of patients with SCC using solid culture media
- Sputum Culture Conversion [ Time Frame: 6 months ] [ Designated as safety issue: No ]Proportion of patients with SCC using the MGIT system
- Durability of Sputum Culture Conversion [ Time Frame: 18 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Distribution of the time to SCC using solid culture media during 6-months of IMP treatment.
- Sputum Culture Conversion [ Time Frame: 6 months ] [ Designated as safety issue: No ]Proportion of patients with SCC using solid culture media
- Durability of Sputum Culture Conversion [ Time Frame: 30 months ] [ Designated as safety issue: No ]Durability of SCC with the MGIT system during the Continuation Treatment and Post-treatment Follow-up periods
| Estimated Enrollment: | 390 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo tablet |
Drug: Placebo
100mg BID for 2 months and 200mg QD for 4 months
|
| Experimental: Delamanid |
Drug: Delamanid
100mg BID for 2 months and 200mg QD for 4 months
|
Detailed Description:
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 15 sites 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 at a limited number of these sites 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.
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424670
Contacts
| Contact: Keinya L Jones, MS | 240.780.4291 | keinya.jones@otsuka-us.com |
Locations
| Estonia | |
| Tartu University Hospital, Lung Clinic | Recruiting |
| Tartu, Estonia, 51014 | |
| Contact: Lia Loime 00372 59030980 lia.loime@covance.com | |
| Principal Investigator: Manfred Danilovits | |
| India | |
| Head of Unit Dept. of TB & Chest Disease, State TB Training & Demostration Centre, B.J. Medical College Civil Hospital Campus, Assarwa | Not yet recruiting |
| Ahmedabad, Gujarat, India, 380016 | |
| Contact: Rajesh Solanki, MD 91 79 22680465 rns04sec@yahoo.co.in | |
| Principal Investigator: Rajesh Solanki, MD | |
| P D Hinduja National Hospital & Research Center, Veer Savarkar Marg | Not yet recruiting |
| Mumbai, India, 400016 | |
| Contact: Zarir Udwadia, MD +91 22 24447363 zfu@hindujahospital.com | |
| Principal Investigator: Zarir Udwadia, MD | |
| Latvia | |
| State Agency "Infectology Center of Latvia" Clinic of Tuberculosis and Lung Diseases | Recruiting |
| Riga, Latvia, LV-2118 | |
| Contact: Rasa Kotello 00371 67914469 rasa.kotello@cratrial.com | |
| Principal Investigator: Andra Cirule, Diploma of Physician | |
| Lithuania | |
| Public Institution Republican Siauliai Hospital Subsidiary Hospital of Tuberculosis and Lung Diseases | Recruiting |
| Siauliai, Lithuania, LT-76231 | |
| Contact: Virginija Gajauskiene 00370 41524336 virginija.gaj@gmail.com | |
| Principal Investigator: Virgaine Bielskiene | |
| Infectious Diseases and Tuberculosis Hospital affiliate of Public institution Vilnius University Hospital | Recruiting |
| Vilnius, Lithuania, LT-10214 | |
| Contact: Egle Garbuziene 00370 52101449 egle.garbuziene@dokumeds.com | |
| Principal Investigator: Valerija Edita Davidaviciene | |
| Moldova, Republic of | |
| Public Medical Sanitary Institution Institute of Phtysiopneumology "Chiril Draganiuc" , MDR TB dept No.1 | Recruiting |
| Chisinau, Moldova, Republic of | |
| Contact: Anna Donica 373 22 899 070 annadonica@rambler.ru | |
| Principal Investigator: Liliana Domente | |
| Peru | |
| SERVICIO DE NEUMOLOGIA-Hospital Nacional Arzobispo Loayza, Av. Alfonso Ugarte 848 | Not yet recruiting |
| Lima, Lima 1, Peru | |
| Contact: Jesus Davila 5 11 7272511 zealot_847@hotmail.com | |
| Principal Investigator: Victor Lizarbe, MD | |
| Hospital Nacional Hipolito Unanue, Avenida Cesar Vallejo 1390 | Recruiting |
| Lima, Peru, 1390 | |
| Contact: Jimmy Merino, MD 511 6279429 jimymerino2005@yahoo.es | |
| Principal Investigator: Patricia Segura, MD | |
| Centro de Investigacion en Enfermedades Neumologicas - Hospital Nacional Sergio E. Bernales, Avenida Tupac Amaru Km 14.5, Urbanizacion Collique, Comas, | Recruiting |
| Lima, Peru, Lima 7 | |
| Contact: Mishiko Sato 511 627 8918 mishikosato@gmail.com | |
| Principal Investigator: Epifanio Sanchez, MD | |
| Unidad de Investigación Clinica - Servicio de Enfermedades Infecciosas y Tropicales - Hospital Nacional Dos de Mayo. Parque de la Medicina Peruana s/n, cuadra 13 Av. Grau. Cercado de Lima | Recruiting |
| Lima, Peru, Lima 1 | |
| Contact: Maria Zavaleta '0115 11 328 2451 malu.zavaleta@yahoo.com.pe | |
| Principal Investigator: Eduardo Ticona, MD | |
| Philippines | |
| De La Salle University (DLSU), Angelo King Medical Research Center, Congressional Avenue | Recruiting |
| Dasmarinas City, Cavite, Philippines, 4114 | |
| Contact: Genevieve Bayas (6346) 481 8000 ext 1388 ivy_vargas2000@yahoo.com | |
| Principal Investigator: Charles Yu, MD | |
| Tropical Disease Foundation, Inc Philippine Institute of Tuberculosis Building. Amorsolo St. cor. Urban Ave., Pio del Pilar | Recruiting |
| Makati City, Manila, Philippines, 1230 | |
| Contact: Rholine Gem Martin Veto, MD 632 751 6021 rsveto@tdf.org.ph | |
| Principal Investigator: Janice Campos-Caoili, MD | |
| Research and Development Office, 4th Floor, Room 4010, Lung Center Philippines, Quezon Avenue | Recruiting |
| Quezon City, Metro Manila, Philippines, 1104 | |
| Contact: Mary Rosary Taguinod, MD (632) 924 6101 ext 205 maryrosarytaguinod@gmail.com | |
| Principal Investigator: Vincent Balanag, MD | |
| Quezon Institute Compound, E. Rodriquez Avenue | Not yet recruiting |
| Quezon City, Metro Manila, Philippines, 1101 | |
| Contact: Eloisa Santiago 63 922 831 3674 santiagoeloisa_1118@yahoo.com | |
| Principal Investigator: Elizabeth Cadena, MD | |
| South Africa | |
| TASK Applied Science, Brooklyn Chest Hospital, 1 Stanberry Road, Ysterplaat, 7421, | Recruiting |
| Cape Town, Cape Town, Western Cape, South Africa, 7421 | |
| Contact: Norma Groenewald 2721 949 7751 norma@task.org.za | |
| Principal Investigator: Florian Von Groote-Bidlingmaier, MD | |
| Head of the Department of Internal Medicine, Klerksdorp/Tshepong Hospital, Anderson Street, Klerksdorp | Recruiting |
| Klerksdorp,, South Africa, 2571, NORTH WEST | |
| Contact: Modiehi Rakgokong 27 18 406 3359 rakgokongm@phru.co.za | |
| Principal Investigator: Ebrahim Variava, MD | |
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
| Study Director: | Carolyn Pettersen, MD | Otsuka Pharmaceutical Development & Commercialization, Inc. |
More Information
No publications provided
| Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| ClinicalTrials.gov Identifier: | NCT01424670 History of Changes |
| Other Study ID Numbers: | 242-09-213 |
| Study First Received: | August 25, 2011 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
|
Multidrug resistant tuberculosis |
Additional relevant MeSH terms:
|
Tuberculosis Tuberculosis, Multidrug-Resistant Mycobacterium Infections |
Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 19, 2013