An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00579982
First received: December 20, 2007
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

To determine the convenience and satisfaction of new orally disintegrating tablet formulation (ODT) of lamictal in subjects with a mood disorder. This was a multicenter, open-label study in participants with a mood disorder, who reported difficulty or discomfort in swallowing the currently marketed IR compressed tablet formulation of lamotrigine and who had a person (such as a spouse, partner, companion, aid, nurse, caregiver, etc) willing to complete a Companion/Caregiver Question. Subjects were switched from the currently marketed lamotrigine IR formulation to a matching dose of lamotrigine IR orally disintegrating tablet (ODT) for 3 weeks to determine convenience and satisfaction.


Condition Intervention Phase
Mood Disorders
Drug: Lamotrigine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Trial Measuring Satisfaction and Convenience of Two Formulations of Lamotrigine in Subjects With a Mood Disorder

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3. [ Time Frame: Baseline, End of Study (Week 3) or Early Withdrawal ] [ Designated as safety issue: No ]
    The CSS is the sum of items 9 (values: 1=Extremely difficult - 7=Extremely easy), 10 (same set of values as for 9), and 11 (1=Extremely inconvenient - 7=Extremely convenient). The sum has 3 subtracted from it, is divided by 18, and then multiplied by 100; the range is 0-100. Change from baseline=end of study CSS minus baseline score.


Secondary Outcome Measures:
  • Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3 [ Time Frame: Baseline, End of Study (Week 3) or Early Withdrawal ] [ Designated as safety issue: No ]
    The Global Satisfaction Subscale Score is the sum of item 12 (values: 1=Not at all confident - 5=Extremely confident), item 13 (values: 1=Not at all certain - 5=Extremely certain), and item 14 (Extremely dissatisfied - 7=Extremely satisfied). The sum has 3 subtracted from it, is divided by 14, and then multiplied by 100; thus, the range is 0-100.

  • Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3 [ Time Frame: Baseline, End of Study (Week 3) or at Early Withdrawal ] [ Designated as safety issue: No ]
    Clinician assessment evaluating how mentally ill the patient is at time of evaluation. The questionnaire is based on a 7-point scale (from1 = Normal to 7 = Among the most extremely ill patients).

  • Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3 [ Time Frame: Baseline, End of Study (Week 3 weeks) or at Early Withdrawal ] [ Designated as safety issue: No ]
    Participant-reported questionnaire consisting of 21 items on a 4 point scale (0 to 3, with 3 indicating most severely ill), with the score being the sum of the items. The change from baseline is the end of study score minus the baseline score; larger values indicate more depression with the ODT formulation relative to the IR formulation.

  • Number of Participants Answering the Question "Did the Tablets Dissolve Instantly (Yes or no)?" at Week 3 [ Time Frame: End of Study (Week 3) or Early Withdrawal ] [ Designated as safety issue: No ]
    The Organoleptic Questionnaire (9 items) was used to assess the participants' satisfaction with the physical characteristics of the ODT formulation e.g. rate of dissolution, flavor. Question number 1 on organoleptic questionnaire: Did the tablets dissolve instantly (yes or no)?

  • Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3 [ Time Frame: Baseline, End of Study (Week 3) or Early Withdrawal ] [ Designated as safety issue: No ]
    Question number 2 on organoleptic questionnaire: How satisfied or dissatisfied were you with the time it took the tablet to dissolve? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]

  • Number of Participants Answering the Question "How Did the Dissolved Tablet Feel in Your Mouth?" at Week 3 [ Time Frame: End of Study (Week 3) or Early Withdrawal ] [ Designated as safety issue: No ]
    Question number 3 on organoleptic questionnaire: How did the dissolved tablet feel in your mouth? [from a rating of 1 (Extremely gritty) to 5 (Extremely smooth)]

  • Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3 [ Time Frame: End of Study (Week 3) or Early Withdrawal ] [ Designated as safety issue: No ]
    Question number 4 on organoleptic questionnaire: How satisfied were you with the flavor of the tablet? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]

  • Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3 [ Time Frame: End of Study (Week 3) or Early Withdrawal ] [ Designated as safety issue: No ]
    Organoleptic Questionnaire, question 5: How would you rate the strength of the flavor of the tablet? [from 1 a rating of (Extremely bothersome) to 5 (Extremely pleasant)]

  • Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3. [ Time Frame: End of Study (Week 3) or Early Withdrawal ] [ Designated as safety issue: No ]
    Organoleptic Questionnaire, question 6: How would you rate the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely bothersome) to 6 (Did NOT experience an aftertaste)]

  • Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3 [ Time Frame: Baseline, End of Study (Week 3) or Early Withdrawal ] [ Designated as safety issue: No ]
    Organoleptic Questionnaire, question 7: How satisfied were you with the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely dissatisfied) to 6 (I did NOT experience an aftertaste)]

  • Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3 [ Time Frame: End of Study (Week 3) or at Early Withdrawal ] [ Designated as safety issue: No ]
    Organoleptic Questionnaire, question 8: Compared to standard tablets that need to be swallowed with liquid, how convenient or inconvenient did you find this orally disintegrating tablet? (from a rating of 1 [Extremely inconvenient] to 5 [Extremely convenient])

  • Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3 [ Time Frame: End of Study (Week 3) or at Early Withdrawal ] [ Designated as safety issue: No ]
    Organoleptic Questionnaire, question 9: Compared to standard tablets that need to be swallowed with liquid, how easy or difficult is it to use this orally disintegrating tablet? [from a rating of 1 (Extremely difficult) to 5 (Extremely easy)]

  • Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3 [ Time Frame: End of Study (Week 3) or at Early Withdrawal ] [ Designated as safety issue: No ]
    Participant indicated whether preference was for ODT or the standard IR tablet

  • Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3 [ Time Frame: End of Study (Week 3) or at Early Withdrawal ] [ Designated as safety issue: No ]
    Companion/Caregiver indicates whether ODT is more convenient or standard IR tablet is more convenient

  • Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation [ Time Frame: End of Study (Week 3) or at Early Withdrawal ] [ Designated as safety issue: No ]
    Tablet Routine Questionnaire (Adherence): Adherence to the treatment was evaluated by asking if the participant would be more likely to take the ODT formulation (yes/no)


Enrollment: 97
Study Start Date: January 2008
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Lamictal orally disintegrating tablet (ODT)
Drug: Lamotrigine
Experimental formulation
Other Name: Lamotrigine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have a documented diagnosis of a mood disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (296.00-296.90).
  • Subject must have a person (such as a spouse, partner, companion, aid, nurse, caregiver, etc) willing to complete a Companion/Caregiver Preference Question either in person or via the telephone. This individual must read, write, and comprehend English at a level sufficient to complete study-related assessments.
  • Subject must have been taking a stable dose of currently marketed compressed tablet formulation of lamotrigine IR for at least 4 weeks prior to Baseline (Day 1) of the study and must be adherent to the prescribed dosing regimen. The current dose must not exceed 600 mg/day.
  • Subject's current lamotrigine IR dose, frequency and number of tablets per administration must remain consistent between the IR and ODT regimens. However, the subject's current lamotrigine IR dose may be such that the subject would receive no more than one additional ODT per administration in order to equal their IR dose.
  • Subject must currently report a difficulty or discomfort swallowing lamotrigine IR compressed tablets, the nature of which is or will be documented. NOTE: A diagnosis of dysphagia is not required.
  • Subject must have the ability to comprehend the consent form and provide informed consent.
  • Subject must read, write, and comprehend English at a level sufficient to complete study-related assessments.
  • Subject is a male or female at least 18 years of age.
  • If female, the subject is eligible to enter and participate in this study if she is not lactating and is of:

    1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal [defined as one year without menses]); is surgically sterile [via hysterectomy and/or removal of the ovaries] or,
    2. child-bearing potential, has a negative pregnancy test at both Screening and/or Baseline (prior to Investigational Product administration), and agrees to one of the following requirements:
  • has a male sexual partner who is surgically sterilized (vasectomy with documentation of azoospermia) prior to Screening or,
  • sexual partner(s) is/are exclusively female or,
  • double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository). The subject must be using this method for at least 1 week following the discontinuation of Investigational Product or,
  • any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year. Acceptable IUDs, for the purposes of this study, include TCu-380A (Paragard), TCU-380 Slimline (Gyne T Slimline), MULTILOAD-250 (MLCu-250) and 375, Levonorgesterol LNG-20 Intrauterine System (Mirena/Levonova), and Flexigard 330/CuFix PP330 (Gynefix).The subject must have had the device inserted at least 2 weeks prior to Screening, throughout the study, and 2 weeks following the discontinuation of Investigational Product.

Exclusion Criteria:

  • Subject has:
  • a current (or within six months prior to Screening) diagnosis of anorexia nervosa or bulimia.
  • a diagnosis of a mood disorder due to a general medical condition, or substance abuse per DSM-IV (293.83).
  • a diagnosis of schizophrenia or other psychotic disorders.
  • Subject who meets current criteria of an acute mood disorder and has a CGI-S of ≥4 at Screening.
  • Subject who crushes lamotrigine IR compressed tablet prior to taking or receiving medication orally.
  • Subject who, in the investigator's judgment, poses a homicidal or serious suicidal risk; has made a suicide attempt within the six months preceding Screening; or has ever been homicidal.
  • Subject who has a score of 1 or greater on Suicidality item (Item 9) of the BDI-II at Screening and/or Baseline.
  • Subject has ever experienced a rash related to prior lamotrigine treatment, or for whom treatment was discontinued for clinically significant safety reasons.
  • Subject has a history of severe hepato-biliary disease within the past 3 years.
  • Subject has any medical condition that, in the investigator's judgment, is considered to be clinically significant and could potentially affect subject safety or study outcome.
  • Subject has a positive urine test at Screening for illicit drug use and/or a history of alcohol or substance abuse or dependence within the past 12 months.
  • Subject is currently participating in another clinical study in which the subject is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month for studies unrelated to the current illness, or six months for studies related to the current illness.
  • Female subject is pregnant, lactating, or does not agree to use contraceptive method(s) specified in the protocol to avoid pregnancy during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579982

Locations
United States, California
GSK Investigational Site
San Diego, California, United States, 92108
GSK Investigational Site
Santa Ana, California, United States, 92705
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32257
GSK Investigational Site
Orange City, Florida, United States, 32763
GSK Investigational Site
Winter Park, Florida, United States, 32792
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30060
United States, Illinois
GSK Investigational Site
Fairview Heights, Illinois, United States, 62208
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55454
United States, Missouri
GSK Investigational Site
St. Charles, Missouri, United States, 63301
United States, New York
GSK Investigational Site
Olean, New York, United States, 14760
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45243
GSK Investigational Site
Cleveland, Ohio, United States, 44106
United States, Texas
GSK Investigational Site
Arlington, Texas, United States, 76012
GSK Investigational Site
Houston, Texas, United States, 77014
GSK Investigational Site
Houston, Texas, United States, 77042
United States, Virginia
GSK Investigational Site
Norfolk, Virginia, United States, 23505
United States, West Virginia
GSK Investigational Site
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00579982     History of Changes
Other Study ID Numbers: LBI108884
Study First Received: December 20, 2007
Results First Received: June 4, 2009
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Mood disorder

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders
Lamotrigine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on August 01, 2014