A clinical trial to study the effects of IP-020 in the treatment of Attention deficit hyperactivity disorder.

Evaluation of Efficacy And Safety of IP-020 in the treatment of Attention deficit hyperactivity disorder (ADHD): A randomized, double-blind, placebo-controlled, multi-center study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001453

Enrollment

200

Registered

2010-10-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: IP-020 Capsule: The recommended dose is one capsule OD for 28 days Control Intervention1: Placebo of IP-020 capsule: The dose is one capsule OD for 28 days

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or Female patients aged 6 to 18. 2. Patients diagnosed with ADHD by DSM-IV for ADHD criteria will be enrolled for the study. 3. Patients whose parents and/or guardians provide written informed consent. (Parents and/or guardians signature is mandatory).

Exclusion criteria

Exclusion criteria: 1. Patients who has concurrent of history of a significant medical or psychiatric illness (schizophrenia, bipolar disorder or autism) that could have interfered with study participation or assessments. 2. Patients who has marked anxiety, tension and agitation. 3. Patients with Cardiovascular disease or problem. 4. Patients with Glaucoma. 5. Patients with a known or suspected history of drug or alcohol abuse or dependence within the previous 6 months. 6. Patients have a history of poor response or intolerance of CNS stimulant viz. amphetamines salts or dextro-amphetamine salts. 7. Patients who are taking Clonidine or other centrally-acting alpha-2-agonists. 8. Patinets who are hypersensitive to Mehylphenidate. 9. Patients with clinically significant abnormal Vital Signs, judged by investigator.

Design outcomes

Secondary

Measure	Time frame
Average change in assessment of Q-LES-Q scores from baseline to end of trial.Timepoint: Baseline Visit (day 0), week 4.	—

Primary

Measure	Time frame
Average change in ADHD symptom scores from baseline to end of trial. Timepoint: Baseline Visit (day 0), week 4.	—

Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results