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Trial Outcomes & Findings for Treatment on Iatrogenic Weight Gain and Dyslipidaemia Associated With Olanzapine (NCT NCT01491490)

NCT ID: NCT01491490

Last Updated: 2014-09-18

Results Overview

Efficacy of a 40:1 ratio of GWP42003:GWP42004 compared with placebo in the change from baseline in body weight after 42 days (6 weeks) in subjects currently being treated with olanzapine for schizophrenia or other non-affective psychosis.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

6 weeks from Baseline.

Results posted on

2014-09-18

Participant Flow

Recruitment was problematic due to the restrictive entry criteria (one subject screened in the first 5 months). Even after implementation of a protocol amendment to improve recruitment, only 12 subjects were screened and two randomised. It was decided that it would be impossible to complete the study in a meaningful timeframe so it was terminated.

There were a high proportion of screen failures due to most subjects failing to comply with one or more of the eligibility criteria.

Participant milestones

Participant milestones
Measure
GWP42003 : GWP42004 (40:1)
Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
Placebo
Taken as 6 capsules, matched to taste and look like the active study medication.
Overall Study
STARTED
1
1
Overall Study
COMPLETED
1
1
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment on Iatrogenic Weight Gain and Dyslipidaemia Associated With Olanzapine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
GWP42003 : GWP42004 (40:1)
n=1 Participants
Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
Placebo
n=1 Participants
Taken as 6 capsules once daily, matched to taste and look like the active study medication.
Total
n=2 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
24 years
STANDARD_DEVIATION NA • n=5 Participants
37 years
STANDARD_DEVIATION NA • n=7 Participants
30.5 years
STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United Kingdom
1 participants
n=5 Participants
1 participants
n=7 Participants
2 participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks from Baseline.

Efficacy of a 40:1 ratio of GWP42003:GWP42004 compared with placebo in the change from baseline in body weight after 42 days (6 weeks) in subjects currently being treated with olanzapine for schizophrenia or other non-affective psychosis.

Outcome measures

Outcome measures
Measure
GWP42003 : GWP42004 (40:1)
n=1 Participants
Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
Placebo
n=1 Participants
Taken as 6 capsules once daily, matched to taste and look like the active study medication.
Change in Bodyweight.
3.6 Kg
1 Kg

Adverse Events

GWP42003 : GWP42004 (40:1)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
GWP42003 : GWP42004 (40:1)
n=1 participants at risk
Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
Placebo
n=1 participants at risk
Taken as 6 capsules once daily, matched to taste and look like the active study medication.
Gastrointestinal disorders
Diarrhoea
100.0%
1/1 • Number of events 1
0.00%
0/1

Additional Information

Mr Colin Stott

GW Research Ltd.

Phone: +44 (0)1980 557000

Results disclosure agreements

  • Principal investigator is a sponsor employee All publications must be submitted to GW for corporate review before release. The principal investigators must then incorporate all reasonable comments made by GW into the publication. GW also reserve the right to delay the submission of such information by up to six months from the date of first submission to them in order to allow them to take steps to protect proprietary information where applicable.
  • Publication restrictions are in place

Restriction type: OTHER